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Comirnaty COVID-19 Vaccine (BioNTech - Pfizer BNT162b2)

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October 20, 2021
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Comirnaty COVID-19 Vaccine (BioNTech - Pfizer BNT162b2) Description

BioNTech S.E. and Pfizer, Inc. co-developed the Comirnaty (BNT162b2) vaccine to prevent severe COVID-19 caused by the SARS-CoV-2 betacoronavirus. The vaccine is based on Germany-based BioNTech S.E. proprietary mRNA technology and was co-developed with Pfizer.

The Comirnaty mRNA BNT162b2 vaccine is a nucleoside-modified RNA formulated in lipid nanoparticles and encodes an optimized SARS-CoV-2 full-length spike protein antigen. 

Comirnaty contains a molecule called messenger RNA (mRNA) with instructions for producing a protein from the SARS-CoV-2 virus. However, Comirnaty does not include the coronavirus itself and cannot cause COVID-19, says the European Medicines Agency.

This Vaccine Information Fact Sheet for Recipients and Caregivers comprises the Fact Sheet for the authorized Pfizer-BioNTech COVID-19 Vaccine. Also, it includes information about the FDA-licensed vaccine, COMIRNATY (COVID-19 Vaccine, mRNA). The European Medicines Agency published a Comirnaty vaccine update EMEA/H/C/005735 on September 24, 2021.

The Comirnaty (Tozinameran) (BNT162b2): Drugbank Accession Number: DB15696; ChemIDplus 434370509; CAS number: 2417899-77-3; STN: 125742UK.

ClinicalTrials.gov Identifier - Phase 3 clinical trials: NCT04805125NCT04368728NCT04713553NCT04754594 (additional studies are listed at this link).

Comirnaty COVID-19 Vaccine (BioNTech - Pfizer BNT162b2) Approvals and Authorizations

The Comirnaty vaccine was issued the first U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for a vaccine to prevent COVID-19 individuals 16 years of age and older on December 11, 2020. In addition, on December 31, 2020, the World Health Organization (WHO) issued an Emergency Use Listing (EUL) for the Comirnaty vaccine. The WHO stated, 'novel Covid-19 mRNA vaccine does not contain the SARS-CoV-2 coronavirus itself and cannot cause COVID-19.'

On May 10, 2021, the FDA's EUA expanded to include people 12 years old. The FDA Approved the Comirnaty (Pfizer-BioNTech) COVID-19 vaccine on August 23, 2021. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for administering the third dose in specific immunocompromised individuals. The FDA Approval was granted to BioNTech Manufacturing GmbH. The U.S. FDA Approved the Comirnaty COVID-19 vaccine for additional people, including individuals 12 through 15 years of age, and for administering the third dose in specific immunocompromised individuals on August 23 2021, and published updated Q&As for Comirnaty on August 27, 2021. The European Medicines Agency (EMA) Approved the Comirnaty vaccine for preventing COVID-19 in people aged 12 years and older on July 29, 2021. The EMA updated EMEA/H/C/005735 on October 15, 2021.

The U.K.'s Medicines and Healthcare products Regulatory Agency approved the Pfizer/BioNTech (Comirnaty) vaccine for use in booster dosing on September 10, 2021. Health Canada issued an Approval for the Pfizer-BioNTech Comirnaty COVID-19 vaccine on September 16, 2021.

On September 17, 2021, Pfizer, Inc. executives presented data to the U.S. FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) information that confirmed the Comirnaty vaccine's effectiveness is compromised by the SARS-CoV-2 virus variant Delta. Leaders from Israel also presented similar diminishing Comirnaty vaccine efficacy. The VRBPAC voted affirmingly to expand access for a 3rd booster dose for seniors and certain people. Also, the VRBPAC agreed that healthcare workers and others at high risk for occupational exposure should be included in this EUA.

On September 22, 2021, the FDA amended the EUA for the Pfizer-BioNTech COVID-19 Vaccine to allow for the use of a single booster dose for certain people to be administered at least six months after completion of the two-dose primary series.

Biopharmaceutical New Technologies (BioNTech S.E.) is the Marketing Authorization Holder in the United States, the European Union, and the United Kingdom, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer), Canada, and other countries. The amendment to the FDA's EUA to include a single booster dose was granted to Pfizer Inc.

Comirnaty COVID-19 Vaccine (BioNTech - Pfizer BNT162b2) History

On July 1, 2020, the manuscript describing the preliminary clinical data for BNT162 was available online for scientific peer-review for potential publication. On July 27, 2020, the Companies advanced nucleoside-modRNA candidate BNT162b2, which encodes an optimized SARS-CoV-2 full-length spike glycoprotein, at a 30µg dose level, in a 2-dose regimen, into Phase 2/3 study of up to 30,000 participants aged 18 – 85 years, and is expected to include approximately 120 sites globally.

Pfizer and BioNTech stated on August 5, 2020, they began a Phase 2b/3 safety and efficacy trial and remained on track to seek regulatory review as early as October 2020. This study was last updated on September 4, 2020.

On August 20, 2020, a non-peer-reviewed abstract found BNT162b2 was associated with less systemic reactogenicity, particularly in older adults. Pfizer provided an update on September 15, 2020, stating: 'Limited blinded tolerability data from the ongoing Phase 3 trial, confirming the mild to moderate tolerability profile as was observed in Phase 1. In the blinded data presented, 50% of trial participants received a placebo, and 50% received BNT162b2.'

On September 12, 2020, the companies announced they have submitted a request to the U.S. FDA to expand the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to up to approximately 44,000 participants, which increases the study's population diversity, and include adolescents as young as 16 years of age and people with chronic, stable HIV, Hepatitis C, or Hepatitis B infection. In addition, on September 17, 2020, Pfizer's overview document for the 'Phase 1/2/3 Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals' became available.

On November 9, 2020, the companies issued a press statement that said the vaccine candidate was found to be more than 90% effective in preventing COVID-19 in (94) participants without evidence of prior SARS-CoV-2 infection first interim efficacy analysis. The phase 3 clinical trial will continue through to the final examination at 164 confirmed cases.

On December 10, 2020, the NEJM published original research that confirmed a 2-dose regimen of BNT162b2 conferred 95% protection against COVID-19 in persons 16 years of age or older. And, safety over a median of 2 months was similar to that of other viral vaccines.

An early release of the CDC's Morbidity and Mortality Weekly Report published on December 13, 2020, stated 'after a detailed, evidence-based review of all available data, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for the use of the Pfizer-BioNTech COVID-19 vaccine in persons aged ≥16 years for the prevention of COVID-19, reported the ACIP website.

On December 14, 2020, the companies announced additional data on neutralizing antibody and T cell responses from the Phase 1/2 trial with BNT162b2 conducted in Germany. The study results demonstrate that BNT162b2 elicits a combined adaptive humoral and cellular immune response against SARS-CoV-2 and provide insights into the composite nature of BNT162b2-induced T cell immunity. The results were published on the preprint server MedRxiv.

A study published by The Lancet on February 22, 2021, concluded by saying, 'this study demonstrates that the BNT162b2 vaccine effectively prevents both symptomatic and asymptomatic infection in working-age adults. And this cohort was vaccinated when the dominant variant in circulation was B1.1.7 and demonstrated effectiveness against this variant.'

On July 15, 2021, The Lancet published a study: Spike-antibody waning after the second dose of BNT162b2. Our data suggest waning of S-antibody levels in infection-naive individuals over a 3–10-week period after the second dose of BNT162b2. These data are consistent with the decline in Spike-antibody and neutralizing antibody levels observed after infection, although memory B-cell populations appear to be maintained. As such, the clinical implications of waning antibody levels post-vaccination are not yet clear, and it remains crucial to establish S-antibody thresholds associated with protection against clinical outcomes.

The companies submitted Phase 1 data to the U.S. FDA on August 16, 2021, to support evaluating a third or booster dose of the Comirnaty (BNT162b2) vaccine for future licensure. 

The Lancet published a Pfizer-funded study on October 4, 2021, showing Comirnaty was 88% effective in the first month after complete 2-dose vaccination but dropped to 47% effectiveness at about six months. Over time, the reduction in vaccine effectiveness against SARS-CoV-2 infections is probably due to waning immunity over time rather than the delta variant escaping vaccine protection.

On October 26, 2021, the U.S. FDA vaccine committee will meet in an open session to discuss a request to amend Pfizer-BioNTech's EUA to administer their COVID-19 mRNA vaccine to children 5 through 11 years old age. The docket number is FDA-2021-N-1088

Biopharmaceutical New Technologies is an immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company published an update on December 2, 2020. New York-based Pfizer's corporation information is updated at this link.

Comirnaty COVID-19 Vaccine (BioNTech - Pfizer BNT162b2) Dosage

The Comirnaty Pfizer-BioNTech COVID-19 Vaccine is offered to various populations in either 1, 2, or 3 dose regimens, subject to country-based authorizations. After preparation, a single dose is 0.3 mL.

On August 12, 2021, the U.S. FDA amended the EUAs for the Pfizer-BioNTech COVID-19 Vaccine to allow for the use of an additional dose in specific immunocompromised individuals, specifically solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromised. 

The CDC's Sara Oliver M.D., MSPH, presented at the ACIP Meeting on August 13, 2021, Considering booster doses of COVID-19 vaccines. Participants in a phase 1 study received a 30-µg booster dose of BNT162b2 8 to 9 months after receiving the second dose. Results from this participant group show that the third dose elicited significantly higher neutralizing antibodies against the initial SARS-CoV-2 coronavirus compared to the levels observed after the two-dose primary series and against the Beta variant and the highly infectious Delta variant.

On August 25, 2021, the companies applied to the U.S. FDA to approve a booster (third) dose of COMIRNATY to prevent COVID-19 in individuals 16 years of age and older. As of September 24, 2021, Comirnaty administered intramuscularly as a three-dose regimen for previously unvaccinated people in the USA was Approved. And the third dose for fully vaccinated people.

The U.K.'s JCVI confirmed on September 14, 2021, 'the JCVI advises a preference for the Pfizer-BioNTech (BNT162b2/ Comirnaty) vaccine to be offered as the third booster dose irrespective of which product was used in the primary schedule. And, the JCVI advises that the booster vaccine dose is offered no earlier than six months after completion of the primary 2-dose vaccine course.'

Pfizer's presentation to the U.S. FDA on September 17, 2021, confirming 'Recent data from Israel and the United States in the context of the delta Variant of Concern predominant circulation suggest that vaccine protection against COVID-19 infection wanes approximately 6 to 8 months following the second dose.' And, data from the Israel Israeli MOH was presented by Sharon Alroy and Ron Milo: Booster protection against confirmed infections and severe disease.

William C. Gruber, M.D., Senior Vice President Vaccine Clinical Research and Development Pfizer Inc., presented an updated 3rd dose (booster) analysis to the ACIP committee on September 22, 2021. A separate presentation by Anne M. Hause, Ph.D. MSPH reported '21,000 v-safe registrants reported an additional dose and 95% of VAERS reports following dose 3 of COVID-19 vaccination were found non-serious.' On September 24, the CDC Director approved delivering a third dose of Comirnaty to most people.

On October 4, 2021, the EMA's human medicines committee (CHMP) concluded that an extra dose of Comirnaty may be given to people with severely weakened immune systems at least 28 days after their second dose. However, there is no direct evidence that the ability to produce antibodies in these patients protected against COVID-19; it is expected that the extra dose would increase protection, at least in some patients. The CHMP also concluded that booster doses (3rd) might be considered at least six months after the second dose for people aged 18 years and older.

Comirnaty COVID-19 Vaccine (BioNTech - Pfizer BNT162b2) Ingredients

Each dose of the Pfizer-BioNTech COVID-19 Vaccine contains 30 mcg of a nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2. And each dose of the Pfizer-BioNTech COVID-19 Vaccine also includes the following ingredients: lipids (0.43 mg (4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2[(polyethylene glycol)-2000]- N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.2 mg cholesterol), 0.01 mg potassium chloride, 0.01 mg monobasic potassium phosphate, 0.36 mg sodium chloride, 0.07 mg dibasic sodium phosphate dihydrate, and 6 mg sucrose. The diluent (0.9% Sodium Chloride Injection, USP) contributes an additional 2.16 mg sodium chloride per dose.

The Pfizer-BioNTech COVID-19 Vaccine does not contain preservatives. The vial stoppers are not made with natural rubber latex. The U.S. CDC publishes 'Common Ingredients in U.S. Licensed Vaccines.'

Comirnaty COVID-19 Vaccine (BioNTech - Pfizer BNT162b2) Side Effects

On December 18, 2020, the journal BMG published a response by Charles J Egmont, Barrister-at-Law Retired, Oxford: 'In the case of the U.K. adverse reactions, a vaccine component Polyethylene Glycol (PEG) was considered to be the primary cause. PEG has been well cited in the medical literature as a pharmaceutical composition that causes severe allergies.'

In clinical trials, safety data indicated reactogenicity symptoms (side effects within seven days of getting vaccinated were expected but mainly mild to moderate. Side effects, such as fever, chills, tiredness, and headache, were more common throughout the body after the second vaccine dose. Again, most side effects were mild to moderate. However, a small number of people had severe side effects—defined as side effects affecting a person's ability to do daily activities, says the U.S. FDA. The U.S. CDC published Possible Side Effects of COVID-19 vaccines on March 5, 2021. And, the CDC published 'Understanding Side Effects and Adverse Events.' The U.S. CDC updated its guidance on May 27, 2021.

The journal Rheumatology published a study on April 13, 2021, that concluded by saying, 'Epidemiologic studies on the safety of the mRNA-based COVID-19 vaccines in patients with autoimmune inflammatory rheumatic diseases are needed to clarify the association between the BNT162b2 mRNA vaccination and reactivation of zoster.'

On May 10, 2021, the FDA stated, 'The most commonly reported side effects in the adolescent clinical trial participants, typically lasted 1-3 days, were pain at the injection site, tiredness, headache, chills, and muscle, fever, and joint pain. The side effects in adolescents were consistent with those reported in clinical trial participants 16 years of age and older.'

As of June 25, 2021, the Fact Sheet for Healthcare Providers Administering Pfizer - BioNTech COVID-19 Vaccine has been revised to include a warning about myocarditis and pericarditis, and the Fact Sheet for Recipients and Caregivers has been changed to include information about myocarditis and pericarditis. In addition, on July 6, 2021, the U.S. CDC published Use of mRNA COVID-19 Vaccine After Reports of Myocarditis Among Vaccine Recipients: Update from the Advisory Committee on Immunization Practices — United States, June 2021.

Health Canada updated the product information for the Pfizer-BioNTech COVID-19 vaccine on August 6, 2021, to describe very rare reports of Bell's Palsy following vaccination.

The NEJM journal published a study based on data from Israel on August 25, 2021, that concluded 'the Comirnaty vaccine was associated with an excess risk of myocarditis 1 to 5 events per 100,000 persons (risk ratio, 3.24; 95% confidence interval [CI], 1.55 to 12.44; risk difference, 2.7 events per 100,000 persons; 95% CI, 1.0 to 4.6). Additionally, the risk of this potentially serious adverse event and many other serious adverse events was substantially increased after SARS-CoV-2 infection.

The U.S. CDC's ACIP committee's presentation slides on August 30, 2021, were published.

On August 31, 2021, the JAMA Network published a study that found 'The rate of allergic reactions to BNT162b2 vaccine, is higher among patients with allergies, particularly among a subgroup with a history of high-risk allergies. This study suggests that most patients with a history of allergic diseases and, particularly, highly allergic patients can be safely immunized by using an algorithm that can be implemented in different medical facilities and includes a referral center, a risk assessment questionnaire, and a setting for immunization under the medical supervision of highly allergic patients.'

The JAMA Network published a new study on September 1, 2021: Rate of Recurrent Guillain-Barré Syndrome After mRNA COVID-19 Vaccine BNT162b2. Forty-eight of 579 patients were seen in an Israeli hospital. Twenty-four had visited the emergency department and were released after less than 24 hours for transient non-neurologic concerns, and the others needed admission for various conditions. Only five were referred to the hospital for neurological problems. 

As of September 9, 2021, the United Kingdom Medicines & Healthcare Regulatory Agency Yellow Card confirmed reports of suspected adverse drug reactions to the Comirnaty vaccine in which the patient died shortly after vaccination, as well as cases of myocarditis - pericarditis, spontaneous adverse reactions associated with anaphylaxis or anaphylactoid reactions.

The EMA issued a Safety Update on October 6, 2021, reporting 361,767 suspected side effects in the EU/EEA.

On October 13, 2021, Parsonage-Turner syndrome was highlighted as a potential adverse effect of mRNA COVID vaccines in a recent pharmacovigilance monitoring report from the French National Agency for the Safety of Medicines and Health Products.

Hui-Lee Wong, Ph.D., MSc, presented Surveillance Updates of Myocarditis/Pericarditis and mRNA COVID-19 Vaccination in the FDA BEST System during the U.S. FDA's VRBPAC meeting on October 14, 2021.

Report an Adverse Event using the VAERS online form or the download. Anyone can submit a report to VAERS, including parents and patients. Healthcare providers in the USA are required by law to report to VAERS.

Comirnaty COVID-19 Vaccine (BioNTech - Pfizer BNT162b2) SARS-CoV-2 Coronavirus Variants

On May 5, 2021, a NEJM CORRESPONDENCE was published: Effectiveness of the BNT162b2 Covid-19 Vaccine against the B.1.1.7 and B.1.351 Variants. The BNT162b2 vaccine effectively against infection and disease in Qatar's population, despite the predominant B.1.1.7 and B.1.351 variants. However, vaccine effectiveness against the B.1.351 variant was approximately 20% lower than the effectiveness (>90%) reported in the clinical trial and real-world conditions in Israel and the United States. In Qatar, as of March 31, 2021, breakthrough infections have been recorded in 6,689 persons who had received one dose of the vaccine and in 1,616 persons who had received two doses.

On June 3, 2021, the Lancet published a research letter that stated: 'Levels of antibodies in the blood of vaccinated people that can recognize and fight the new SARS-CoV-2 Delta variant first discovered in India (B.1.617.2) are on average lower than those against previously circulating variants in the U.K., according to new laboratory data from the Francis Crick Institute and the National Institute for Health Research UCLH Biomedical Research Centre.'

The journal Nature published an article on June 10, 2021: BNT162b2-elicited neutralization of B.1.617 and other SARS-CoV-2 variants.

A new analysis by PHE published on June 14, 2021, shows the Pfizer-BioNTech vaccine is 96% effective against hospital admission with the Delta (B.1.617.2) variant.

On July 4, 2021, Ynet news reported the Israeli health ministry announced from June 6 to July 2, 2021, the vaccine demonstrated 64% efficacy at preventing cases and 94% effectiveness at preventing hospitalizations. And, Politico reported Public Health England said data published on July 2, 2021, suggests vaccine effectiveness against symptomatic disease from one dose of the vaccines in use provides between 55 to 70 percent efficacy. Data on two doses indicates the efficacy of around 65 to 90%.

The NEJM published an ORIGINAL ARTICLE on July 28, 2021, Covid-19 Breakthrough Infections in Vaccinated Health Care Workers. This study based in Israeli found a 2.6% COVID breakthrough reinfection rate of the Alpha variant in health care staff.

On August 19, 2021, Oxford University published a study that concluded by saying 'SARS-CoV-2 vaccination still reduces new infections, but the vaccine's effectiveness and attenuation of peak viral burden are reduced with SARS-CoV-2 Delta virus variant.'

A non-peer-review study conducted by researchers in Japan reported on August 23, 2021, 'although Pfizer-BioNTech BNT162b2-immune sera neutralized the Delta variant, when four common mutations were introduced into the receptor-binding domain of the Delta variant (Delta 4+), some BNT162b2-immune sera lost neutralizing activity and enhanced the infectivity.'

Pfizer disclosed in its presentation to the U.S. FDA on September 17, 2021, 'A retrospective cohort study conducted at Kaiser Permanente Southern California suggests that the observed erosion in Cominraty vaccine effectiveness is likely primarily due to waning effectiveness rather than due to Delta escaping vaccine protection, given that (i) effectiveness against Delta infections was >90% early on; (ii) vaccine effectiveness decreases with increasing time since being fully vaccinated, irrespective of variant; and (iii) effectiveness against Delta variant hospitalizations remained high over the entire study period.'

Comirnaty COVID-19 Vaccine (BioNTech - Pfizer BNT162b2) For Children

Children: Pfizer confirmed on March 25, 2021, they have dosed the first healthy children in a global Phase 1/2/3 continuous study to evaluate further the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine in 4,644 children between the ages of 11 years to 6 months.

In May 2021, the UAE Ministry of Health and Prevention approved the emergency local use of Pfizer vaccine for children between the ages of 12 and15 following clinical trials and a strict assessment. However, on June 1, 2021, the AAP published an article that found boys aged 14 to 19 received Pfizer vaccinations in April or May 2021 and developed chest pain within a few days. In addition, heart imaging tests showed a type of heart muscle inflammation called myocarditis.

On June 10, 2021, Reuters reported Germany's STIKO vaccine advisory committee recommended that only children and adolescents with pre-existing conditions be given the Pfizer - BioNTech vaccine. Additionally, STIKO said that doctors were allowed to give the shot if the individual accepted the risk.

The CDC reported during the U.S. FDA Center for Biologics Evaluation and Research meeting on June 10, 2021, among all age groups, there have been 573 cases of myocarditis and pericarditis reported after people received their second dose of either mRNA vaccine, compared to 216 after the first dose. Among 16-to-17-year-olds, who had received 2.3 million doses since Authorization, 79 cases of myocarditis or pericarditis were reported. Limited outcome data suggest most patients (81%) had complete recovery of symptoms.

During the CDC's ACIP meeting on June 23, 2021, Tom Shimabukuro, MD, MPH, MBA Vaccine Safety Team, presented 'Early safety data of Pfizer-BioNTech vaccination in persons aged 12–15 years old.'

The U.K.'s JCVI announced on July 19, 2021; it advises that children at increased risk of serious COVID-19 disease are offered the Pfizer-BioNTech vaccine. This includes children aged 12 to 15 with severe neurodisabilities, Down's syndrome, immunosuppression, and multiple or severe learning disabilities. The JCVI also recommends that children and young people aged 12 to 17 who live with an immunosuppressed person be offered the vaccine. On August 4, 2021, the U.K.'s Joint Committee on Vaccination and Immunisation issued an advisory that all 16 and 17-year-olds should receive their first dose of the Pfizer-BioNTech vaccine.

On July 22, 2021, the Australian Therapeutic Goods Administration granted Pfizer Australia Pty Ltd provisional approval for its COVID-19 vaccine, COMIRNATY, in individuals aged 12 years and older.

The journal JAMA published a new study on August 10, 2021. In this small case series study, myocarditis was diagnosed in children after COVID-19 vaccination, most commonly in boys after the second dose. In this case series, in short-term follow-up, patients were mildly affected. The long-term risks associated with postvaccination myocarditis remain unknown.

On August 23, 2021, the American Academy of Pediatrics issued a statement that strongly discourages the administration of the Comirnaty vaccine off-label for children aged 11 and younger. In addition, Dr. Rochelle P. Walensky announced her endorsement of the CDC Advisory Committee on Immunization Practices' recommendation for using Pfizer-BioNTech's licensed vaccine for people 16 and older on August 30, 2021.

The EMA confirmed on September 6, 2021; it has started evaluating an application for the use of a booster (3rd) dose of Comirnaty to be given six months after the second dose in people aged 16 years and older. And the EMA started evaluating an application to extend the use of BioNTech/Pfizer's COVID-19 vaccine, Comirnaty, to children aged 5 to 11 on October 18, 2021.

The U.K.'s JCVI published an update on September 2, 2021, 'Overall, the committee is of the opinion that the benefits from vaccination are marginally greater than the potential known harms (tables 1 to 4) but acknowledges that there is considerable uncertainty regarding the magnitude of the potential harms.' So then, the chief medical officers of England, Scotland, Wales, and Northern Ireland recommended on September 13, 2021, that children aged 12 to 15 be given a single dose of the Pfizer/BioNTech Comirnaty vaccine.

In an evaluation conducted in Israel, among individuals ≥16 years of age, BNT162b2 effectiveness against SARS‑CoV-2 infection was only 39.0% (95% CI: 9.0%, 59.0%) and against symptomatic COVID-19 was 40.5% (95% CI: 8.7%, 61.2%) between 20 June 2021 and 17 July 2021. This was considerably lower than published effectiveness estimates from an earlier time period, stated Pfizer's presentation to the U.S. FDA on September 17, 2021.

Pfizer and BioNTech announced on September 20, 2021, results from a Phase 2/3 trial showing a favorable safety profile and robust neutralizing antibody responses in children 5 to 11 years of age using a two-dose regimen of 10 µg administered 21 days apart, a smaller dose than the 30 µg dose used for people 12 and older. The antibody responses in the participants given 10 µg doses were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age immunized with 30 µg doses.

The U.S. CDC reported on October 19, 2021, among hospitalized U.S. patients aged 12–18 years, vaccine effectiveness of 2 doses of Pfizer-BioNTech vaccine against COVID-19 hospitalization during June–September 2021, was 93% (95% confidence interval = 83%–97%).

The FDA's VRBPAC will meet in an open session on October 26, 2021, to discuss a request to amend Pfizer-BioNTech's EUA for the administration of their COVID-19 mRNA vaccine to children 5 through 11 years of age.

Comirnaty COVID-19 Vaccine (BioNTech - Pfizer BNT162b2) Indication For Women

The journal Nature Medicines published results from a new study on September 7, 2021: Effectiveness of the BNT162b2 mRNA COVID-19 vaccine in pregnancy. In summary, the BNT162b2 mRNA vaccine was estimated to have high vaccine effectiveness in pregnant women, similar to the general population's effectiveness.

A retrospective cohort study published by the JAMA on July 12, 2021, found pregnant women in Israel were at significantly lower risk of SARS-CoV-2 infection when vaccinated with the BioNTech - Pfizer vaccine, compared with no vaccination. Therefore, on August 20, 2021, Israel's Health Ministry authorized the Comirnaty vaccine for pregnant women.

On April 21, 2021, the NEJM published original research that concluded by saying, 'Preliminary findings did not show obvious safety signals among pregnant women who received mRNA COVID-19 vaccines, or neonatal outcomes.

Comirnaty COVID-19 Vaccine (BioNTech - Pfizer BNT162b2) Indication For Cancer Patients

Two studies published by the journal Blood on April 16, 2021, evaluated immune responses to the BNT162b2 mRNA COVID-19 vaccine in patients with chronic lymphocytic leukemia and seniors diagnosed with multiple myeloma. These studies suggest that mRNA-based COVID-19 vaccines may not work as well in people with blood cancer. General Principles of COVID-19 Vaccines for Immunocompromised Patients (Version 3.0; last updated April 5, 2021).

In a cohort study of patients with cancer who received active systemic therapy published by the JAMA on May 28, 2021, 90% of patients exhibited adequate antibody response to the BNT162b2 vaccine. However, their antibody titers were significantly lower than those of healthy controls. Further research into the clinical relevance of lower titers and their durability is required.

On July 8, 2021, the JAMA Oncology published: Serologic Status and Toxic Effects of the SARS-CoV-2 BNT162b2 Vaccine in Patients Undergoing Treatment for Cancer. Conclusions and Relevance - In this cohort study, the SARS-CoV-2 BNT162b2 vaccine appeared safe and achieved satisfactory serologic status in patients with cancer. There was a pronounced lag in antibody production compared with the rate in noncancer controls. However, seroconversion occurred in most patients after the second dose. Future real-world data are warranted to determine the long-term efficacy of the vaccine concerning the type of anticancer treatment.

The National Comprehensive Cancer Network® (NCCN®) announced on August 30, 2021, enhancements to the NCCN: Cancer and COVID-19 Vaccination guidance. The fourth version incorporates the latest data and recent FDA and CDC approvals regarding a third mRNA vaccine dose for immunocompromised people.

Comirnaty COVID-19 Vaccine (BioNTech - Pfizer BNT162b2) Indication For Multiple Sclerosis Patients

In this study published by the JAMA Network on September 23, 2021, the humoral response against SARS-CoV-2 at 1 month after mRNA vaccination was appropriate under treatment with cladribine and teriflunomide and diminished/absent under treatment with anti-CD20 therapies and S1P modulators. Delaying anti-CD20 infusions by 3 to 6 months before vaccination could, however, increase the probability of developing appropriate humoral responses, especially in selected clinically and radiologically stable patients. Future studies should aim at investigating antibody dynamics over time, if and how T cell-mediated responses after vaccination are influenced by DMTs, and whether these biological measures actually reflect vaccine efficacy in terms of preventing severe SARS-CoV-2 infection.

On June 9, 2021, based on expert consensus and available data, the National Multiple Sclerosis Society offered the following guidance regarding COVID-19 vaccination for people on MS disease-modifying therapies. This guidance applies to people with MS ages 12 and older and only for the vaccines authorized for use for their age in the United States.

An earlier study published on April 22, 2021, showed impaired humoral response to COVID-19 vaccination for MS patients on ocrelizumab and S1P receptor modulators.

Comirnaty COVID-19 Vaccine (BioNTech - Pfizer BNT162b2) Distribution

The U.S. government issued distribution authorization on December 11, 2020. On January 22, 2021, Pfizer and BioNTech S.E. announced an advance purchase agreement with COVAX for up to 40 million doses of the Pfizer-BioNTech COVID-19 Vaccine. The Companies announced on February 12, 2021, that the U.S. government had exercised its option for an additional 100 million doses of the Pfizer-BioNTech COVID-19 vaccine. This brings the total number of doses supplied by the companies to the U.S. government to 300 million. Consistent with the agreements for the initial 200 million doses, the U.S. government will pay $1.95 billion for the additional 100 million doses.

On April 14, 2021, the E.C.'s President von der Leyen announced that 'we have reached an agreement with BioNTech-Pfizer to deliver 250 million doses in the second quarter. Based on all this, the contract foresees the delivery of 1.8 billion doses of vaccine through 2023. On April 19, 2021, the Companies announced they would supply an additional 100 million doses of COMIRNATY to the 27 European Union member states in 2021. 

Brazil's Anvisa authorized a new manufacturing site for the Comirnaty vaccine on July 28, 2021, by the Company Pfizer. The new manufacturing plant is Hospira Inc., located in McPherson, Kansas. And on August 26, 2021, Pfizer and BioNTech announced the signing of a letter of intent with Eurofarma Laboratórios SA, a Brazilian biopharmaceutical company, to manufacture COMIRNATY for distribution within Latin America.

The EMA's human medicines committee approved on September 9, 2021, additional manufacturing sites for the production of Comirnaty. One site, located in Frankfurt am Main, Sanofi-Aventis Deutschland GmbH operates Germany. The other in Hameln, also in Germany, is operated by Siegfried Hameln GmbH. Both sites will manufacture the finished product. These sites will provide up to 50 million additional doses in 2021. On October 18, 2021, the EMA's CHMP approved two additional manufacturing sites for the production of Comirnaty. One site, located in Monza, Italy, is operated by Patheon Italia S.p.A. The other in Anagni, also in Italy, is operated by Catalent Anagni S.R.L. These sites will produce up to 85 million additional doses to supply the EU in 2021.

BioNTech - Fosun Pharma

BioNTech is also collaborating with Fosun Pharma to develop the BNT162 vaccine in China. On March 13, 2020, Fosun Pharma became the strategic partner of BioNTech in China, jointly developing and commercializing vaccine products for COVID-19 based on its proprietary mRNA technology platform in Mainland China, Hong Kong, the Macau Special Administration Region, and the Taiwan Region. Furthermore, on May 9, 2021, BioNTech agreed to Fosun Pharma's heads to establish a 50/50 Joint Venture to manufacture about 1 billion COVID-19 vaccines in China.

Comirnaty COVID-19 Vaccine (BioNTech - Pfizer BNT162b2) Cold Storage

On February 25, 2021, the U.S. FDA announced that it allows undiluted frozen vials of the Comirnaty Vaccine to be transported and stored at conventional temperatures found in pharmaceutical freezers period of up to two weeks. This reflects an alternative to the undiluted vials' preferred storage in an ultra-low temperature freezer between -80ºC to -60ºC (-112ºF to -76ºF).

On May 17, 2021, the EMA approved the storage period of the unopened thawed vial at 2-8°C (i.e., in a standard fridge after taking out of deep freeze conditions) from five days to one month. On October 18, 2021, the CHMP approved a ready-to-use formulation of Comirnaty. This formulation does not require dilution prior to administration, will be available in a 10-vial (60 doses) pack size, and can be stored at 2-8°C for up to 10 weeks. The current concentrated formulation requires dilution prior to administration, is available in a 195-vial (1,170 doses) pack size, and can be stored at 2-8°C for up to one month).

Comirnaty COVID-19 Vaccine (BioNTech - Pfizer BNT162b2) Indication

Comirnaty (BNT162b2) is an mRNA vaccine intended to prevent severe COVID-19 in humans. Do not administer Comirnaty to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component Pfizer-BioNTech COVID-19 Vaccine, says the U.S. FDA.

Comirnaty COVID-19 Vaccine (BioNTech - Pfizer BNT162b2) CPT Code

The American Medical Association helps identify the appropriate CPT code combination (91300) for the type and dose of the COVID-19 vaccine provided to patients. The American Medical Association has updated the CPT code to reflect the booster/third dose, 0003A. Medicare also covers a Pfizer COVID-19 vaccine booster shot at least 6 months after you complete your second dose of the Pfizer COVID-19 vaccine series if you're 65 and older or for certain people at high risk.

Comirnaty COVID-19 Vaccine Distribution

As of October 10, 2021, the Comirnaty COVID-19 Vaccine is available in the USA, BrazilCanadaEurope, ItalyQatar, Iceland, Finland, the U.K., and various countries.

Comirnaty COVID-19 Vaccine (BioNTech - Pfizer BNT162b2) News

October 18, 2021 - Health Canada received a submission from Pfizer-BioNTech seeking authorization for the use of its Comirnaty COVID-19 vaccine in children 5 to 11 years of age.

October 8, 2021 - In recent days, there has been data from Nordic countries on the increased incidence of myocarditis and pericarditis after vaccination with Moderna vaccine in addition to vaccination with Pfizer / BioNTech (Comirnaty). Epidemiologists have decided that the Moderna vaccine will not be used in Iceland.

October 7, 2021 - A non-peer-reviewed study assessed SARS-CoV-2-Spike (S)-targeted antibody and functional T cell responses at around 6 months after complete vaccination. Findings: Almost all residents displayed detectable SARS-CoV-2-S-reactive antibodies and T cell responses, respectively, by around 6 months after complete vaccination with Comirnaty® COVID-19 vaccine, albeit generally waning in magnitude over time.

October 7, 2021 - Finland's National Institute for Health and Welfare instructed municipalities to administer the Comirnaty vaccine to men under the age of 30.

October 6, 2021 - The journal NEJM published an ORIGINAL ARTICLE: Waning of BNT162b2 Vaccine Protection against SARS-CoV-2 Infection in Qatar. CONCLUSIONS - BNT162b2-induced protection against SARS-COV-2 infection appeared to wane rapidly following its peak after the second dose. And protection against hospitalization and death persisted at a robust level for 6 months after the second dose. Funded by Weill Cornell Medicine–Qatar and others.

October 4, 2021 - A Pfizer-funded retrospective cohort study reported a significant reduction in vaccine effectiveness against SARS-CoV-2 infections over time (6 months) is probably primarily due to waning immunity with time rather than the delta variant escaping vaccine protection.

October 4, 2021 - The EMA's human medicines committee concluded that an extra dose of the COVID-19 vaccines Comirnaty (BioNTech/Pfizer) may be given to people with severely weakened immune systems, at least 28 days after their second dose. Although there is no direct evidence that the ability to produce antibodies in these patients protected against COVID-19, it is expected that the extra dose would increase protection at least in some patients. 

September 28, 2021 - Pfizer Inc. and BioNTech SE announced they have submitted data to the U.S. Food and Drug Administration from the Phase 2/3 trial of their COVID-19 vaccine in children 5 to <12 years of age. A formal submission to request Emergency Use Authorization of the companies' COVID-19 vaccine in children 5 to <12 years of age is expected to follow in the coming weeks. Submissions to the European Medicines Agency and other regulatory authorities are also planned. Topline immunogenicity and safety readouts for the other two age cohorts from the trial – children 2 to <5 years of age and children 6 months to <2 years of age – are expected as soon as the fourth quarter of this year.

September 28, 2021 - Brazil's Anvisa received a request from Pfizer to change the approved dosage for the Comirnaty vaccine. Pfizer's application of a booster dose in volunteers who received the two initial doses of the Comirnaty vaccine for at least 6 months. The proposal involves all age groups currently included in the package insert, that is, people 12 years of age or older.

September 24, 2021 - The U.S. CDC Director Rochelle P. Walensky, M.D., M.P.H., endorsed the CDC's Advisory Committee on Immunization Practices' recommendation for a booster shot of the Pfizer-BioNTech COVID-19 vaccine in certain populations and also recommended a booster dose for those in high risk occupational and institutional settings.

September 23, 2021 - Pfizer Inc. announced that its board of directors declared a 39-cent fourth-quarter 2021 dividend on the Company's common stock, payable December 6, 2021, to holders of the Common Stock of record at the close of business on November 5, 2021. 

September 23, 2021 - The U.S. CDC's vaccine committee reviewed various risks and benefits regarding a 3rd booster dose of the Comirnaty vaccine for certain populations. Sara Oliver, M.D., MSPH, presented 'Evidence to Recommendation Framework.'

September 20, 2021 - The Companies reported a Phase 2/3 study that enrolled children 6 months to 11 years of age, and for 2,268 participants who were 5 to 11 years of age, who received a 10 µg dose level in a two-dose regimen. In the trial, the SARS-CoV-2–neutralizing antibody geometric mean titer (GMT) was 1,197.6 (95% confidence interval [CI, 1106.1, 1296.6]), demonstrating a strong immune response in this cohort of children one month after the second dose. This compares well (was non-inferior) to the GMT of 1146.5 (95% CI: 1045.5, 1257.2) from participants ages 16 to 25 years old, used as the control group for this analysis and who were administered a two-dose regimen of 30 µg. Further, the COVID-19 vaccine was well tolerated, with side effects generally comparable to those observed in participants 16 to 25 years of age.

September 17, 2021 - Pfizer and BioNTech had received reports in Japanese cities that white to off-white opaque amorphous particles have been found in vials of "Comirnaty" manufactured by BioNTech. We have conducted a full investigation of the reports from Kamakura-city, Sagamihara-city, and Sakai-city related to white / off-white opaque amorphous particles found in vials. We confirm that there is no safety issue regarding the presence of these particles found in these vials (Lot #. FF5357). These particles have been determined to be an intrinsic component of the vaccine and are not attributable to a product quality issue.

September 17, 2021 - The U.S. FDA vaccine committee vote affirmingly to expand access for a 3rd booster dose for seniors and certain people. This vaccine committee also agreed that healthcare workers and others at high risk for occupational exposure should be included in this EUA.

September 17, 2021 - Pfizer and BioNTech published a presentation for the U.S. FDA vaccine committee review meeting. Dr. Oliver's presentation indicates the Delta coronavirus variant has significantly reduced protection against infection (including asymptomatic or mild infections) from the 380 million COVID-19 vaccines administered in the USA during the June-July timeframe. And, data from the Israel Israeli MOH, Weizmann Institute of Science, Gertner Institute, Hebrew University & Technion, was presented: Booster protection against confirmed infections and severe disease.

September 17, 2021 - The U.S. CDC issued an MMWR: Comparative Effectiveness of Moderna, Pfizer-BioNTech, and Janssen Vaccines in Preventing COVID-19 Hospitalizations Among Adults Without Immunocompromising Conditions. Among U.S. adults without immunocompromising conditions, vaccine effectiveness against COVID-19 hospitalization during March 11–August 15, 2021, was higher for the Moderna vaccine (93%) than the Pfizer-BioNTech vaccine (88%) and the Janssen vaccine (71%).

September 16, 2021 - Pfizer Canada ULC and Germany-based BioNTech S.E. confirmed Health Canada granted Approval for COMIRNATY® to prevent COVID-19 in individuals 12 years of age and older.

September 15, 2021 - The NEJM published an ORIGINAL ARTICLE: Protection of BNT162b2 Vaccine Booster against Covid-19 in Israel. CONCLUSIONS - In this study involving participants who were 60 years of age or older and had received two doses of the BNT162b2 vaccine at least five months earlier, we found that the rates of confirmed Covid-19 and severe illness were substantially lower among those who received a booster (third) dose of the BNT162b2 vaccine.

September 14, 2021 - Foreign matter has been found in five unused vials of Pfizer Inc.'s COVID-19 vaccine in two cities near Tokyo and one in Osaka Prefecture, reported Kyodo News. These cities have requested Pfizer to analyze the substances. The vials containing the white floating matter belong to the same lot, FF5357. The Comirnaty vaccine was initially approved in Japan in February 2021.

September 13, 2021 - Britain's chief medical officer, Professor Chris Whitty, recommended that children between the ages of 12 and 15 be offered the COVID-19 vaccine.

September 10, 2021 - Dr. June Raine, the U.K.'s MHRA Chief Executive, commented: 'We are committed to getting safe and effective COVID-19 vaccines to the U.K. public. I am pleased to confirm that the COVID-19 vaccines made by Pfizer can be used as safe and effective booster doses.'

September 9, 2021 - The U.S. President issued an Executive Order on Requiring Coronavirus Disease 2019 Vaccination for Federal Employees.

September 5, 2021 - The Lancet Regional Health Europe published a new study that concluded by stating, 'The mRNA vaccine induces a strong antibody response to SARS-CoV-2 and five VOCs at 1-week post-vaccination that decreases after that. Although detectable in the majority, T cell responses were lower in individuals with higher T cell immunosenescence. And the deterioration of vaccine response suggests the need to monitor for the potential booster vaccination.'

August 31, 2021 - The Children's Health Defense filed suit in U.S. District Court, Eastern District of Tennessee, against the U.S. Food and Drug Administration and its acting director, Dr. Janet Woodcock, for their allegedly deceptive, rushed licensure of the Comirnaty vaccine.

August 31, 2021 - The JAMA Network published a news study based in Israel that concluded 'a simple algorithm enables immunization of most patients with a history of allergy, while only patients defined as highly allergic should receive vaccination under medical supervision.'

August 30, 2021 - The Smithsonian Magazine published an article: Why the Pfizer-BioNTech Covid-19 Vaccine Is called Comirnaty?

August 25, 2021 - Pfizer Inc. and BioNTech S.E. announced the initiation of a supplemental Biologics License Application (sBLA) to the U.S. FDA to approve a booster dose of COMIRNATY® to prevent COVID-19 in individuals 16 years of age and older. The companies intend to complete the submission of the sBLA by the end of this week.

August 24, 2021 - The U.S. DOD mandated vaccinations (Comirnaty) for the military. The memo states that service members actively participating in COVID-19 clinical trials are exempt from mandatory vaccination until the trial is complete to avoid invalidating clinical trial results.

August 24, 2021 - The EMA approved an additional manufacturing site to produce Comirnaty, the COVID-19 vaccine developed by BioNTech and Pfizer. Located in Saint Rémy sur Avre, France, the site is operated by Delpharm and will manufacture the finished product. The site will allow providing approximately up to 51 million additional doses in 2021. The EMA has also approved a new manufacturing line at BioNTech's manufacturing site in Marburg, Germany, which will increase the active substance manufacturing capacity by approximately 410 million doses in 2021.

August 23, 2021 - The U.S. FDA issued its Approval for the Comirnaty Vaccine to BioNTech Manufacturing GmbH.

August 20, 2021 - A non-peer-reviewed study - Significant reduction in humoral immunity among healthcare workers and nursing home residents 6 months after COVID-19 BNT162b2 mRNA vaccination. Healthcare workers, given their younger age and relatively good health, achieved higher initial antibody levels and better maintained them, yet also experienced significant declines in humoral immunity.

August 18, 2021 - Public health and medical experts from the U.S. Department of Health and Human Services released a statement on the administration's plan for COVID-19 booster shots for the American people.

August 16, 2021 - The Companies announced they submitted Phase 1 data to the U.S. FDA to support evaluating a third dose of the COVID-19 vaccine (BNT162b2) for future licensure.

August 13, 2021 - The CDC's Advisory Committee on Immunization Practices endorsed using an additional dose of COVID-19 vaccine for people with moderately to severely compromised immune systems after an initial two-dose vaccine series.

August 11, 2021 - The EMA published an updated report regarding potential side effects. The PRAC started assessing erythema multiforme (E.M.; a hypersensitivity (allergic) reaction with characteristic round skin lesions, which may also affect mucous membranes in internal body cavities) to establish whether it is a side effect of Comirnaty. And, the PRAC started an assessment of glomerulonephritis (inflammation of tiny filters in the kidneys) and nephrotic syndrome (kidney disorder causing the kidneys to leak too much protein in the urine) to establish whether they may be side effects of Comirnaty. And discussed reported cases of menstrual disorders occurring after vaccination against COVID-19.

August 9, 2021 - Germany-based BioNTech S.E. announced for the six months ended June 30, 2021, total revenues were estimated to be €7,356.9 million compared to €69.4 million for the comparative prior-year period. The increase was mainly due to rapid increases in the supply of COVID-19 vaccines worldwide. As of July 21, 2021, BioNTech and its partner Pfizer, Inc. have shipped approximately one billion doses of BNT162b2 to more than 100 countries or territories worldwide. The companies have signed orders of more than 2.2 billion doses for delivery in 2021 and more than one billion doses for 2022 and beyond as of July 21, 2021. 

July 28, 2021 - Pfizer Inc. revealed the BNT162b2 vaccine contributed $7.8 billion in direct sales and alliance revenues and indicated 2.1 billion vaccine doses are expected to be delivered in 2021. Pfizer presented its expanded mRNA vaccine strategy on slide #22.

July 23, 2021 - Pfizer Inc. and BioNTech S.E. announced that the U.S. government had purchased an additional 200 million doses of the Pfizer-BioNTech COVID-19 Vaccine. These doses are expected to be delivered from October 2021 through April 2022. 

July 22, 2021 - The University College London announced 'total antibody levels appear to start declining from as early as six weeks after complete vaccination and can reduce by more than 50% over ten weeks,' according to new data from the Virus Watch study.

July 19, 2021 -  BioNTech S.E. and Kite, a Gilead Company (Nasdaq: GILD, "Kite"), announced the two companies have entered into a purchase agreement for BioNTech to acquire Kite's solid tumor neoantigen T cell receptor (TCR) R&D platform and clinical manufacturing facility in Gaithersburg, MD.

July 16, 2021 - Pfizer Inc. and BioNTech S.E. announced that the U.S. Food and Drug Administration granted Priority Review designation for the Biologics License Application for their mRNA vaccine to prevent COVID-19 in individuals 16 years age and older. The Prescription Drug User Fee Act goal date for a decision by the FDA is in January 2022.

July 15, 2021 - A new study, 'Spike-antibody waning after the second dose of BNT162b2', was published by The Lancet.

July 14, 2021 - The EMA reported as of July 4, 2021, a total of 206,668 cases of suspected side effects with Comirnaty were reported to EudraVigilance from EU/EEA countries; 3,848 of these reported a fatal outcome. These figures cannot be extracted directly from the public database of suspected adverse reactions, which groups information per type of side effects. As more than one suspected side effect may have been included in a single case report, the total number of side effects will never match the number of individual cases.

July 12, 2021 - BioNTech S.E. announced that Fosun Industrial Co., Limited had reached advance procurement agreements for the mRNA-based COVID-19 vaccine BNT162b2 with Taiwan Semiconductor Manufacturing Co., Ltd., Hon Hai Precision Industry Co., Ltd., Yonglin Charity Foundation, and Zuellig Pharma, Inc. respectively. Fosun Industrial will sell a total of 10 million doses of COVID-19 mRNA vaccines to Zuellig Pharma entrusted by TSMC, Hon Hai, and Yonglin. In addition, these COVID-19 mRNA vaccines will be donated to the relevant agency of disease control of the Taiwan region for local vaccination.

July 9, 2021 - The United Kingdom Medicines & Healthcare Regulatory Agency announced it had received 450 Yellow Card reports of suspected adverse drug reactions to the Pfizer- BioNTech (Comirnaty) vaccine in which patients died shortly after vaccination.

June 25, 2021 - The U.S. FDA stated 'the warning in the Fact Sheets for Healthcare Providers Administering Vaccines notes that reports of adverse events suggest increased risks of myocarditis and pericarditis, particularly following the second dose with the onset of symptoms within a few days after vaccination. Additionally, the Fact Sheets for Recipients and Caregivers for these vaccines note that vaccine recipients should seek medical attention right away if they have chest pain, shortness of breath, or feelings of having a fast-beating, fluttering, or pounding heart after vaccination.'

June 22, 2021 - The EMA's Committee for human medicines approved additional manufacturing sites to produce Comirnaty, the COVID-19 vaccine developed by BioNTech and Pfizer. One site, located in Reinbek, Germany, is operated by Allergopharma GmbH & Co. K.G. The other in Stein, Switzerland, is operated by Novartis Pharma.

June 14, 2021 - PHE published 'Effectiveness of COVID-19 vaccines against hospital admission with the Delta (B.1.617.2) variant.'

June 10, 2021 - The journal Nature published an early version of a study: BNT162b2-elicited neutralization of B.1.617 and other SARS-CoV-2 variants. 'Geometric mean plaque reduction neutralization titers against the variant viruses, particularly the B.1.617.1 variant, appear lower than the titer against USA-WA1/2020 virus, but all sera tested neutralize the variant viruses at titers of at least 40.'

June 2, 2021 - Following reports of myocarditis cases around the time of vaccination, the Israeli Ministry of Health has appointed an extended epidemiological team to investigate the possible link between these cases and the Pfizer-BioNTech vaccine. In addition, since April 2021, the U.S. CDC says 'there have been increased reports to the Vaccine Adverse Event Reporting System of cases of myocarditis and pericarditis happening after mRNA COVID-19 vaccination (Pfizer-BioNTech and Moderna) in the USA. However, these reports are rare, given the number of vaccine doses administered.

May 28, 2021 - The JAMA published an Original Investigation: Evaluation of Seropositivity Following BNT162b2 Messenger RNA Vaccination for SARS-CoV-2 in Patients Undergoing Treatment for Cancer. The findings of this study suggest that patients with cancer who are receiving active treatment and are at higher risk for severe COVID-19 disease respond well to messenger RNA SARS-CoV-2 vaccines and that vaccination of these patients should be seriously considered.

May 28, 2021 - The EMA's human medicines committee has recommended granting an extension of indication for the COVID-19 vaccine Comirnaty to include use in children aged 12 to 15.

May 27, 2021 - The NEJM published a study that concluded, 'The BNT162b2 vaccine in 12-to-15-year-old recipients had a favorable safety profile, produced a greater immune response than in young adults, and was highly effective against Covid-19.' Across 29 U.S. sites, between October 15, 2020, and January 12, 2021, 1,131 participants received BNT162b2, and there were no vaccine-related serious adverse events and few overall severe adverse events. Among BNT162b2 recipients, severe adverse events were reported in 0.6% of those aged 12 to 15 and 1.7% of those 16 to 25 years of age. No deaths were reported. This report includes safety data through 1 month of follow-up after dose 2 for some participants. Data on longer-term safety and the duration of efficacy and antibody responses in children are not yet available.

May 27, 2021 - A study published by the journal Nature confirmed: BNT162b2 elicits an adaptive humoral and poly-specific cellular immune response against epitopes conserved in a broad range of variants at well-tolerated doses.

May 24, 2021 - Pfizer Inc. announced that the first enrolled subjects had received their immunizations as part of a new study in adults ages 65 or older exploring the Company's 20-valent pneumococcal coadministration conjugate vaccine (20vPnC) candidate following a booster dose of the Pfizer-BioNTech COVID-19 Vaccine.

May 21, 2021 - BioNTech S.E. published its first Sustainability Report.

May 20, 2021 - BioNTech Europe GmbH has agreed with Turkey's Ministry of Health to supply 60 million additional doses of the companies' COVID-19 vaccine, with an option of 30 million doses. This second supply agreement brings the total number of doses to Turkey to up to 120 million, delivered in 2021.

May 20, 2021 - Pfizer Inc. and BioNTech S.E. announced a new agreement with the European Commission (E.C.) to supply 900 million doses of COMIRNATY with an option for the E.C. to request up to an additional 900 million doses. Inclusive of all agreements, up to 2.4 billion vaccine doses for the E.C. are planned to be manufactured in the E.U.

May 20, 2021 - The NEJM published a response to a Letter to the Editor. Among persons with three or more coexisting conditions, the estimated vaccine effectiveness was 81% (95% confidence interval [CI], 69 to 90) against documented infection and 88% (95% CI, 79 to 95) against symptomatic infection — findings that support the initial indications of potentially reduced vaccine effectiveness in this subgroup. There were also indications of potentially reduced vaccine effectiveness among persons with certain conditions, such as heart disease, chronic kidney disease, and cerebrovascular disease. The number of control-matched pairs of solid-organ recipients for at least 7 days after receiving the second dose was too small to evaluate vaccine effectiveness.

May 12, 2021 - The U.S. CDC's ACIP emergency meeting agenda and presentation slides were posted. This ACIP focuses on the recently Authorized Safety, immunogenicity, and efficacy of Pfizer - BioNTech COVID-19 Vaccine (BNT162b2) in persons aged 12-15 years. During the afternoon session, the ACIP voted in support of the U.S. FDA's expanded Authorization.

May 11, 2021 - BioNTech S.E. announced today that the U.S. Food and Drug Administration had expanded the Emergency Use Authorization for their COVID-19 vaccine to include individuals 12 to 15 years of age. This is the first COVID-19 vaccine authorized in the U.S. for use in this age group.

May 10, 2021 - The U.S. FDA expanded the EUA for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age.

May 10, 2021 - BioNTech S.E. announced plans to establish a fully integrated mRNA manufacturing facility in Singapore with support from the Singapore Economic Development Board. The new facility will provide regional and global supply capacity of BioNTech's growing pipeline of mRNA-based product candidates. The Company anticipates that the site could be operational as early as 2023 and will create up to 80 jobs in Singapore.

May 9, 2021 - BioNTech agreed to Fosun Pharma's heads to establish a 50/50 Joint Venture (J.V.) to manufacture the COVID-19 vaccine in Mainland China. The establishment of a J.V. will be conditional on BioNTech receiving approval for its COVID-19 vaccine in Mainland China and agreement with Fosun Pharma on a definitive J.V. agreement, in addition to other conditions. As part of its global supply strategy, BioNTech believes that establishing local manufacturing capacity for the COVID-19 vaccine could substantially increase the Company's ability to supply vaccines to China upon approval.

May 7, 2021 - Pfizer Inc. and BioNTech S.E. announced the initiation of a Biologics License Application with the U.S. FDA to approve their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older.

April 23, 2021 - The Lancet published 'COVID-19 vaccine coverage in England's healthcare workers and effectiveness of BNT162b2 mRNA vaccine against infection (SIREN): a prospective, multicentre, cohort study.' Interpretation: Our findings show that the BNT162b2 vaccine can prevent both symptomatic and asymptomatic infections in working-age adults. This cohort was vaccinated when the dominant variant in circulation was B1.1.7 and showed effectiveness against this variant.

April 1, 2021 - The companies announced updated topline results from analysis of 927 confirmed symptomatic cases of COVID-19 observed in their pivotal Phase 3 study through March 13, 2021, showing the Pfizer-BioNTech COVID-19 vaccine, BNT162b2, was 91.3% effective against COVID-19.

March 15, 2021 - The JAMA published a new study: Immunogenicity of a Single Dose of SARS-CoV-2 Messenger RNA Vaccine in Solid Organ Transplant Recipients. Transplant recipients receiving anti–metabolite maintenance immunosuppression therapy were less likely to develop an antibody response than those not receiving such immunosuppression therapy (37% vs. 63%, respectively; adjusted incidence rate ratio [IRR], 0.22 [95% CI, 0.15-0.34], P < .001).

March 8, 2021 - The NEJM published Neutralizing Activity of BNT162b2-Elicited Serum follow-up article. These researchers (with industry conflicts) found various levels of neutralizing antibodies (geometric mean titers (GMT)) were generated against all of the SARS-CoV-2 variants.

February 25, 2021 - Pfizer Inc. and Germany-based BioNTech S.E. announced they had begun an evaluation of the safety and immunogenicity of a third dose of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) to understand the effect of a booster on immunity against COVID-19 caused by the circulating and potential newly emerging SARS-CoV-2 variants.

February 19, 2021 -  Pfizer Inc. and BioNTech S.E. announced the submission of new data to the U.S. FDA demonstrating the stability of their COVID-19 vaccine when stored at -25°C to -15°C (-13°F to 5°F).

February 17, 2021 - The NEJM published a Letter to the Editor by Canadian researchers, Danute Skowronski, with the British Columbia Centre for Disease Control, and Gaston De Serres, with the Institut National de Sante Publique du Quebec, noting that using the same data submitted to the U.S. FDA, they calculated that before the second dose, the Comirnaty vaccine was still "highly efficacious," with an efficacy of 92.6%.

February 2, 2021 - Pfizer announced its financial results, including information regarding the Comirnaty vaccine. As of January 31, 2021, Pfizer supplied 65M doses globally, of which 29M were supplied to the U.S. Government.

January 27, 2021 - Sanofi and BioNTech announced they have entered into an agreement under which Sanofi will support the manufacturing and supply of BioNTech's COVID-19 vaccine, co-developed with Pfizer.

January 25, 2021 - The Therapeutic Goods Administration of Australia has granted provisional approval to Pfizer Australia Pty Ltd for the Comirnaty COVID-19 vaccine, the first COVID-19 vaccine to receive regulatory approval.

January 21, 2021 - JAMA Insights - Clinical Update: Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine. From December 14 to 23, 2020, after administering a reported 1,893,360 first doses of Pfizer-BioNTech COVID-19 vaccine, the CDC identified 21 case reports submitted to VAERS that met Brighton Collaboration case definition criteria for anaphylaxis, corresponding to an estimated rate of 11.1 cases per million doses administered. No deaths from anaphylaxis were reported.

December 31, 2020 - The NEJM study reported, 'A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older. Safety over a median of 2 months was similar to that of other viral vaccines.'

December 31, 2020 - The WHO listed the Comirnaty COVID-19 mRNA vaccine for emergency use, making it the first to receive emergency validation from the WHO. 

December 21, 2020 - Pfizer Inc. and BioNTech S.E. announced that the European Commission had granted a conditional marketing authorization for COMIRNATY® (also known as BNT162b2) for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus in individuals 16 years of age and older. 

December 15, 2020 - Presented by the Orthodox Union and the Rabbinical Council of America: our poskim conclude that, according to the advice of your personal health care provider, the Torah obligation to preserve our lives and the lives of others requires us to vaccinate for COVID-19 as soon as a vaccine becomes available.

December 11, 2020 - The U.S. FDA issued the first emergency use authorization for a vaccine to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus in individuals 16 years of age and older. The emergency use authorization allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the U.S.

December 10, 2020 - The Kingdom of Saudi Arabia's Food and Drug Agency registered the Pfizer-BioNTech COVID-19 vaccine for import and use, according to state news agency SPA.

October 13, 2020 - Pfizer Inc. expanded its Phase 3 clinical trial for the BNT162b2 vaccine candidate has received permission from the U.S. FDA to enroll children aged 12 and older.

September 15, 2020 - BioNTech S.E. announced that it would receive a grant of up to 375 million euros from the German Federal Ministry of Education and Research (BMBF) initiative to support the accelerated development of SARS-CoV-2 vaccines.

July 22, 2020 - Pfizer and BioNTech S.E. announced the execution of an agreement with the U.S. government to meet the Operation Warp Speed program's goal to begin delivering 300 million doses of a vaccine for COVID-19 in 2021. 

April 22, 2020 - Pfizer Inc. and BioNTech S.E. confirmed they have entered into a global collaboration agreement to co-develop BioNTech's mRNA-based coronavirus vaccine program to prevent COVID-19 infection.

March 16, 2020 - BioNTech also announced a strategic alliance with Fosun Pharma to develop its COVID-19 vaccine in China.

Comirnaty COVID-19 Vaccine (BioNTech - Pfizer BNT162b2) Clinical Trials

Comirnaty has been tested in over 80 clinical trials since the first quarter of 2020. 

Pfizer's website displays various clinical trial participant metrics.

Clinical Trials