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BioNTech - Pfizer COVID-19 Vaccine

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

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

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

The Pfizer-BioNTech COVID-19 mRNA 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. On May 10, 2021, the FDA's EUA was expanded to include people 12 years old. However, the experimental Pfizer-BioNTech COVID-19 vaccine has not been Approved or Licensed by the FDA.

The U.S. CDC issued Interim Clinical Considerations for the use of mRNA COVID-19 Vaccines Currently Authorized in the United States on January 21, 2021.

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 February 11, 2021, the U.S. CDC vaccine committee issued Interim Clinical Considerations for the use of mRNA COVID-19 Vaccines Currently Authorized in the United States.

The U.S. CDC updated its 'Pfizer-BioNTech COVID-19 Vaccine Overview and Safety on April 5, 2021. And on April 28, 2021, the CDC Morbidity and Mortality Weekly Report confirmed 'In a multistate network of U.S. hospitals during January–March 2021, receipt of Pfizer-BioNTech (Comirnaty) vaccine was about 94% effective against COVID-19 hospitalization among fully vaccinated adults and 64% effective among partially vaccinated adults aged ≥65 years.

The Pfizer-BioNTech COVID-19 vaccine (Comirnaty) (Tozinameran) (BNT162b2): Drugbank Accession Number: DB15696; ChemIDplus 434370509; CAS number: 2417899-77-3

BioNTech - Pfizer COVID-19 Vaccine (Comirnaty) 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.

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 analysis 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 an explicit, 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.'

Biopharmaceutical New Technologies is an immunotherapy company pioneering novel therapies for cancer and other serious diseases. The company published a corporate update on December 2, 2020.

New York-based Pfizer's corporation information is updated at this link.

BioNTech - Pfizer COVID-19 Vaccine (Comirnaty) 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.

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. Heart imaging tests showed a type of heart muscle inflammation called myocarditis.

Pfizer's CEO @AlbertBourla tweeted on June 8, 2021, 'I’m excited we have begun dosing participants aged 5 to 11 in a global Phase 2/3 study of the Pfizer-BioNTech COVID19 vaccine.' @megtirrell with CNBC Tweeted, 'Pfizer says it's selected lower doses for #covid19 vaccine trials in kids: -10 micrograms for ages 5-11 -3 ug for 6 mo-4.'

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 accepts 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 full recovery of symptoms. The CDC continues to recommend COVID-19 vaccination for everyone 12 years of age and older, given the risk of COVID-19 illness and related, possibly severe complications.

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

In February 2021, Pfizer and BioNTech dosed the first participant in a global Phase 2/3 study to evaluate further the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine in preventing COVID-19 in healthy pregnant women 18 years of age and older. Unfortunately, data are not available to assess Pfizer-BioNTech COVID-19 Vaccine's effects on the breastfed infant or milk production/excretion.

A separate study published by the JAMA on April 12, 2021, found robust secretion of SARS-CoV-2 specific IgA and IgG antibodies in breast milk for 6 weeks after vaccination. IgA secretion was evident as early as 2 weeks after vaccination, followed by a spike in IgG after 4 weeks (a week after the second vaccine).

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. However, local and systemic vaccine reactions reported to the V-Safe Surveillance System were similar among persons who identified as pregnant and nonpregnant women. Among 3,958 participants enrolled in the V-Safe Pregnancy Registry, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth. Adverse neonatal outcomes included preterm birth (9.4%) and small size for gestational age (in 3.2%). Among pregnancy-specific conditions reported to the VAERS systems after the mRNA COVID-19 vaccination, miscarriage was the most common. 

BioNTech - Pfizer COVID-19 Vaccine (Comirnaty) 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.

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

Summary of safety data: In clinical trials, reactogenicity symptoms (side effects within 7 days of getting vaccinated were expected but mostly 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 European Medicines Agency safety update issued on March 4, 2021, reflects data collected and assessed since Comirnaty’s authorization, including data from EudraVigilance (the EU’s centralized database of suspected side effects) and data received from other sources, including the company’s monthly safety report required for COVID-19 vaccines. Diarrhea and vomiting after vaccination have been identified as new side effects.

On May 10, 2021, the FDA stated, 'The most commonly reported side effects in the adolescent clinical trial participants, which typically lasted 1-3 days, were pain at the injection site, tiredness, headache, chills, muscle pain, 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 May 18, 2021, 155 deaths had been reported in Norway after vaccination with the Pfizer-BioNTech vaccine, confirmed the BMJ. 'A review reported on May 19th concluded that a causal link between the Pfizer-BioNTech vaccine and death was considered “likely” in 10 of the 100 cases, “possible” in 26 cases, and “unlikely” in 59 cases. The remaining five were deemed “unclassifiable.”

On June 4, 2021,  Singapore's Ministry of Health reported 'there are also approximately 2,000 individuals who had developed anaphylaxis or allergic reactions (hives, face/ eyelid/ lip/ throat swelling, generalized rash within 7 days after vaccination) due to the first dose of an mRNA COVID-19 vaccine. Therefore, this group should not receive an mRNA-based vaccine again.'

As of June 9, 2021, the United Kingdom Medicines & Healthcare Regulatory Agency had received 421 Yellow Card reports of suspected adverse drug reactions to the Pfizer-BioNTech vaccine in which the patient died shortly after vaccination; 39 reports of myocarditis, and 27 reports of pericarditis following use of the Pfizer/BioNTech vaccine; 376 spontaneous adverse reactions associated with anaphylaxis or anaphylactoid reactions. The nature and frequency of these reports are in line with that reported in previous updates, says the MHRA.

For Comirnaty, as of June 11, 2021, the EMA's PRAC is reviewing cases of myocarditis and pericarditis in the context of a safety signal, under an accelerated timetable (finalization expected in July). A safety signal is a piece of information on a new or incompletely documented adverse event potentially caused by medicine such as a vaccine, which warrants further investigation.

BioNTech - Pfizer COVID-19 Vaccine (Comirnaty) 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 was effective 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 UK, according to new laboratory data from the Francis Crick Institute and the National Institute for Health Research UCLH Biomedical Research Centre.'

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.

BioNTech - Pfizer COVID-19 Vaccine (Comirnaty) 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.'

BioNTech - Pfizer COVID-19 Vaccine (Comirnaty) Distribution

The US government issued distribution authorization on December 11, 2020. On December 23, 2020, the U.S. government announced it would purchase an additional 100 million doses of the Pfizer/BioNTech COVID-19 vaccine.

On January 22, 2021, Pfizer and BioNTech SE announced an advance purchase agreement with COVAX for up to 40 million doses of the Pfizer-BioNTech COVID-19 Vaccine. The doses will be delivered throughout 2021.

Pfizer Inc. and BioNTech SE 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 to be supplied by the companies to the U.S. government to 300 million. Consistent with the agreements for the prior 200 million doses, the U.S. government will pay $1.95 billion for the additional 100 million doses.

On April 14, 2021, the EC'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 June 10, 2021, the U.S. government confirmed it would buy 500 million more doses of the Pfizer-BioNTech COVID-19 vaccine to share through the COVAX alliance for donation to lower-income countries and the African Union over the next two years.

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.

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

On February 25, 2021, the U.S. FDA announced that it allows undiluted frozen vials of the Pfizer-BioNTech COVID-19 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). The change is reflected in updates to the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers).

On March 26, 2021, the companies announced, 'New stability data show vaccine can be stored at -25°C to -15°C for a total of two weeks and support decentralized distribution plans for vaccination at EU general practitioners offices.' In addition, other countries may require the BNT162b2 vaccine to be stored and transported at ultracold temperatures below −70 °C (−94 °F) since the vaccine degrades within 5 days when thawed says the company.

On May 17, 2021, the EMA approved the storage period of the unopened thawed vial at 2-8°C (i.e., in a normal fridge after taking out of deep freeze conditions) from five days to one month (31 days). 

BioNTech - Pfizer COVID-19 Vaccine (Comirnaty) Indication

Comirnaty (BNT162b2) is an experimental mRNA vaccine intended to prevent COVID-19 in humans aged 12-85. Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component Pfizer-BioNTech COVID-19 Vaccine. On December 9, 2020, the UK's NHS issued an advisory regarding a potential risk for those with severe allergies. The NHS stated, 'the COVID-19 mRNA Vaccine BNT162b2 is not recommended during pregnancy.

BioNTech - Pfizer COVID-19 Vaccine (Comirnaty) Dosage

The Pfizer-BioNTech COVID-19 Vaccine is administered intramuscularly as a series of two doses (0.3 mL each) three weeks apart. After dilution, one vial contains 6 doses of 0.3 mL. Vial labels and cartons may state that a vial contains 5 doses of 0.3 mL after dilution. The information in this January 2021 FDA Fact Sheet regarding the number of doses per vial after dilution supersedes the number of doses stated on vial labels and cartons.

There is limited data on the Pfizer-BioNTech COVID-19 Vaccine interchangeability with other COVID-19 vaccines to complete the vaccination series. However, if mRNA COVID-19 vaccines are administered within 14 days of another vaccine, doses do not need to be repeated for either vaccine, says the CDC.

On June 7, 2021, a new study published by The JAMA found 'the first vaccine dose was associated with 54% effectiveness against symptomatic COVID-19, in a 'comparative effectiveness study of 503,875 individuals.'

BioNTech - Pfizer COVID-19 Vaccine (Comirnaty) 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.

BioNTech - Pfizer COVID-19 Vaccine (Comirnaty) News

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 9, 2021 - A new Israeli population-based study published in Open Forum Infectious Diseases found 89% vaccine effectiveness 7 or more days after the second dose. In this study, vaccination with BNT162b2 reduced infection rates among individuals who underwent screening by frequent SARS-CoV-2 PCR testing. In addition, using a cohort of frequently tested individuals reduced the indication bias for the PCR testing, which enabled the estimation of infection rates.

June 2, 2021 - Local media reported France's President Emmanuel Macron confirmed adolescents between 12-18 would become eligible for COVID-19 vaccination on June 15, 2021.

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.

June 1, 2021 - The EMA recommended the approval of additional manufacturing and filling lines at Pfizer’s vaccine manufacturing site in Puurs, Belgium. The recommendation by the EMA’s Committee for Human Medicines is expected to have a significant and immediate impact on the supply of Comirnaty, the COVID-19 vaccine developed by BioNTech and Pfizer, in the European Union.

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. The vaccine is already approved for use in adults and adolescents aged 16 and above. The committee noted that the trial could not have detected rare side effects due to the limited number of children included in the study. The committee also noted that EMA’s safety committee is currently assessing very rare cases of myocarditis and pericarditis after vaccination with Comirnaty, mainly in people under 30 years of age. Currently, there is no indication that these cases are due to the vaccine. The EMA stated it is closely monitoring this issue.

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 years of age and in 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 SE 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 for an additional 30 million doses. This second supply agreement brings the total number of doses to Turkey to up to 120 million, all of which will be delivered in 2021.

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

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 receipt of the second dose was too small to evaluate vaccine effectiveness.

May 18, 2021 - The Canadian National Advisory Committee on Immunization issued new advice to the federal, provincial, and territorial governments on the recommended use of the Pfizer-BioNTech COVID-19 vaccine in adolescents 12 to 15 years of age. On May 5, 2021, Health Canada authorized using the Pfizer-BioNTech COVID-19 mRNA vaccine in adolescents 12 to 15 years of age.

May 18, 2021 - Bahrain approved Pfizer/BioNtech vaccine for adolescents aged from 12 to 17 years, the Bahrain News Agency reported.

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 SE 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.  “The FDA’s expansion of the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age is a significant step in the fight against the COVID-19 pandemic,” said Acting FDA Commissioner Janet Woodcock, M.D., in a press release. However, at this time, there are limited data to address whether the vaccine can prevent transmission of the virus from person to person. In addition, at this time, data are not available to determine how long the vaccine will provide protection.

May 10, 2021 - BioNTech announced more than 450 million doses of BNT162b2 had been supplied to 91 countries or territories as of May 6, 2021.

May 10, 2021 - BioNTech SE 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 (JV) to manufacture the COVID-19 vaccine in Mainland China. The establishment of a JV will be conditional on BioNTech receiving approval for its COVID-19 vaccine in Mainland China and agreement with Fosun Pharma on a definitive JV 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 SE announced the initiation of a Biologics License Application with the U.S. Food and Drug Administration (FDA) to approve their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. The Prescription Drug User Fee Act goal date for a decision by the FDA will be set once the Application is complete and formally accepted for review by the FDA.

May 5, 2021 - The US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices has scheduled an 'emergency meeting' on May 12, 2021, without disclosing the agenda.

May 5, 2021 - Media reported, “After completing a thorough and independent scientific review of the evidence, the (Health Canada) department determined that this vaccine is safe and effective when used in this younger age (12-15) group,” said Health Canada’s chief medical adviser Dr. Supriya Sharma. 

May 4, 2021 - New York-based Pfizer Inc. published today its 'Key Near-term Potential Milestones for COVID-19 Vaccine Program (2021)' on slide #7 within its financial report. This chart indicates Pfizer plans to file for full US Food and Drug Administration (FDA) Approval of its experimental COVID-19 vaccine (BNT162b2) in May 2021, about six months after receiving an FDA Emergency Use Authorization (EAU). Furthermore, Pfizer may seek a EUA for vaccinating toddlers in November'21. Pfizer expects to manufacture at least 3 billion vaccine doses in 2022 (vs. 2.5B doses in 2021) from a production capability perspective. Per Pfizer's slide #6, anticipated revenue from the Pfizer-BioNTech COVID-19 vaccine could reach $26 billion in 2021.

May 3, 2021 - The European Medicines Agency announced an application to extend the COVID-19 vaccine Comirnaty to include young people aged 12 to 15 under evaluation.

April 23, 2021 - The Lancet published 'COVID-19 vaccine coverage in health-care workers in England 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 23, 2021 - The European Medicines Agency (EMA) announced an increase in vaccine manufacturing capacity and supply for mRNA COVID-19 vaccine produced by BioNTech - Pfizer. The EMA approved an increase in batch size and associated process scale-up at Pfizer’s vaccine manufacturing site in Puurs, Belgium.

April 19, 2021 - CEO Albert Bourla @PfizerTweeted 'governments worldwide are working on longer-term pandemic preparedness. Today we signed our first 2022 government agreement with Israel to supply millions of doses of the Pfizer-BioNTech COVID19 vaccine with the option to purchase millions of additional doses.

April 19, 2021 - Pfizer Inc. and BioNTech SE announced they would supply an additional 100 million doses of COMIRNATY®, the companies’ COVID-19 vaccine, to the 27 European Union (EU) member states in 2021. 

April 14, 2021 - The EC announced it was 'entering into a negotiation with BioNTech-Pfizer for a third contract. This contract will foresee the delivery of 1.8 billion doses of vaccine over the period of 2021 to 2023.

April 9, 2021 - Pfizer Inc. and BioNTech SE announced they requested amendments to the U.S. EUA of the Pfizer-BioNTech Vaccine (BNT162b2) to expand the use in adolescents 12 to 15 years of age. These requests are based on data from the pivotal Phase 3 trial in adolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection, which demonstrated 100% efficacy and robust antibody response after vaccination COVID-19 Vaccine.

April 5, 2021 - The U.S. CDC published an update to its Pfizer-BioNTech COVID-19 Vaccine Overview and Safety overview.

April 2, 2021 - The U.S. CDC published: Interim Estimates of Vaccine Effectiveness of BNT162b2 COVID-19 Vaccines in Preventing SARS-CoV-2 Infection Among Health Care Personnel, First Responders, and Other Essential and Frontline Workers. 

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. These results were measured seven days through up to six months after the second dose. Furthermore, the experimental vaccine was 100% effective against severe COVID-19 as defined by the US government.

March 31, 2021 - The companies announced in a press release, 'In 2,260 participants aged 12-15 years old, BNT162b2 demonstrated 100% efficacy and robust antibody responses, exceeding those reported in the phase 3 trial of vaccinated 16-25-year-old participants in an earlier analysis, and was well tolerated.

March 26, 2021 - BioNTech SE announced that the European Medicines Agency (EMA) approved the COVID-19 vaccine drug product manufacturing at the facility in Marburg. The approvals make BioNTech’s Marburg manufacturing site one of the largest mRNA vaccine manufacturing sites in Europe and worldwide, with an annual production capacity of up to one billion doses of our COVID-19 vaccine, once fully operational.

March 25, 2021 - The Pfizer website revealed details of a new phase 3 study with the Pfizer-BioNTech COVID-19 vaccine focused on infants older than six months up to children 11 years of age. These study participants will evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine on a two-dose schedule (approximately 21 days apart) in three age groups. Children younger than 6 months of age may subsequently be evaluated once an acceptable safety profile has been established.

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 11, 2021 - A non-peer-reviewed study reported 'What level of neutralizing antibody (from vaccination) protects from COVID-19?

March 10, 2021 - The European Commission agreed with BioNTech-Pfizer to supply four million more doses of COVID-19 vaccines for Member States in the next two weeks to address coronavirus hotspots and facilitate free border movement.

March 9, 2021 - People previously infected with the SARS-CoV-2 virus may produce levels of antibodies against COVID-19 after one dose of the Pfizer–BioNTech COVID-19 vaccine that is equal to or higher than people not previously infected have after two doses, found researchers from NYU Grossman School of Medicine.

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. The GMT was highest against the original variant and the B.1.1.7 variant first detected in the UK, slightly lower against the P.1 variant, and lower still against the B.1351 variant first identified in South Africa.

March 7, 2021 - New Zealand's Prime Minister Jacinda Ardern and Covid-19 Response Minister Chris Hipkins announced the purchase of 8.5 million doses of the Pfizer-BioNTech Covid vaccine, reported local media. These vaccines are expected to arrive during the second half of 2021.

March 4, 2021 - The EMA announced the latest safety data for this vaccine are in line with the known benefit-risk profile; the outcomes of the related assessments are presented in this update.

March 3, 2021 -  Pfizer Inc. and BioNTech SE, and UNICEF announced the arrival of the first doses of their COVID-19 vaccine in Rwanda through the COVAX Facility. 

February 25, 2021 - Pfizer Inc. and Germany-based BioNTech SE 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 22, 2021 - Data analyzed by Public Health England (PHE) shows the Pfizer-BioNTech vaccine provides high levels of protection against infection and symptomatic disease from the first dose. 

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

February 18, 2021 - Pfizer Inc. and BioNTech SE announced they would be commencing a global clinical trial to evaluate the COVID-19 vaccine in pregnant women. This phase 2/3 study will evaluate the vaccine's safety, tolerability, and immunogenicity in preventing COVID-19 in healthy pregnant women 18 years and older.

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 17, 2021 - NEJM Preliminary Report: Neutralizing Activity of BNT162b2-Elicited Serum. 'Our data are also consistent with poorer neutralization of the virus with the full set of B.1.351-spike mutations than SARS-CoV-2 virus with either subset of mutations and suggested that virus with mutant residues in the receptor-binding site (K417N, E484K, and N501Y) is more poorly neutralized than the coronavirus with Δ242-244, which is located in the N-terminal domain of the spike protein.'

February 14, 2021 - FUJIWARA Yasuhiro, M.D., Ph.D. Chief Executive Pharmaceuticals and Medical Devices Agency announced the first COVID-19 vaccine applied by Pfizer Japan Inc. was granted Special Approval for Emergency in Japan. 

February 11, 2021 - Researchers from Bar-Ilan University and Ziv Medical Center now report preliminary evidence that people previously infected with the virus responded very strongly to one dose of the Pfizer vaccine, regardless of when they were infected and whether or not they had detectable antibodies against COVID-19 before receiving the vaccine. 

February 8, 2021 - BioNTech SE and Pfizer announced the publication in Nature Medicine of data from in vitro studies that demonstrate that sera from individuals vaccinated with the Pfizer-BioNTech COVID-19 vaccine neutralize SARS-CoV-2 with key mutations present in the United Kingdom and South African variants.

February 4, 2021 - The University of Oxford announced it is leading a study to explore alternating different COVID-19 vaccines, explore the potential for flexibility in delivery, and look for clues about increasing the breadth of protection against new virus strains. The study, run by the National Immunisation Schedule Evaluation Consortium, will evaluate the feasibility of using a different vaccine for the initial ‘prime’ vaccination to the follow-up ‘booster’ vaccination.

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 doses were supplied to the U.S. Government.

January 29, 2021 - Report published by Science: Neutralization of SARS-CoV-2 lineage B.1.1.7 pseudovirus by BNT162b2 vaccine-elicited human sera. These data indicate that the B.1.1.7 lineage will not escape BNT162b2-mediated protection.

January 29, 2021 - The European Medicines Agency (EMA) released its first safety update on the COVID-19 vaccine Comirnaty. It concludes that safety data collected on Comirnaty use in vaccination campaigns are consistent with the vaccine's known safety profile, and no new side effects were identified.

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. Sanofi will provide BioNTech access to its established infrastructure and expertise to produce over 125 million doses of the Comirnaty COVID-19 vaccine in Europe. Initial supplies will originate from Sanofi’s production facilities in Frankfurt from the summer of 2021.

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.

January 20, 2021 - Pfizer Inc. and BioNTech SE announced results from an in vitro study that provides additional data on sera's capability from individuals immunized with the Pfizer-BioNTech COVID-19 vaccine BNT162b2 to neutralize the SARS-CoV-2 B.1.1.7 lineage or VOC 202012/01.

January 13, 2021 - The Lancet published 'European Medicines Agency's EU conditional marketing authorizations for COVID-19 vaccines.'

January 8, 2021 - BioNTech SE announced results from an in vitro study conducted by Pfizer and the University of Texas Medical Branch that shows the antibodies from people who have received the Pfizer-BioNTech COVID-19 vaccine effectively neutralize SARS-CoV-2 with a key mutation that is also found in two highly transmissible strains.

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 29, 2020 - Pfizer Inc. and BioNTech SE announced they would supply an additional 100 million doses of COMIRNATY®, the companies’ COVID-19 Vaccine, to the 27 European Union member states in 2021.

December 21, 2020 - Pfizer Inc. and BioNTech SE 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 18, 2020 - The journal BMG published a response by Charles J Egmont, Barrister-at-Law Retired, Oxford: 'In the case of the UK adverse reactions, a vaccine component Polyethylene Glycol (PEG) was considered to be the primary cause. Apparently, PEG has been well cited in the medical literature as a pharmaceutical composition that causes severe allergies.'

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 14, 2020 - Pfizer Inc. and BioNTech SE 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.

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 has registered the Pfizer-BioNTech COVID-19 vaccine for import and use in the country, state news agency SPA reported.

December 9, 2020 - Pfizer Canada and BioNTech SE announced that Health Canada had granted Authorization under Interim Order for the emergency use of their mRNA COVID-19 vaccine (BNT162b2).

December 4, 2020 - The Company's presentation: Next Generation Immunotherapy, was published. 

November 25, 2020 - BioNTech SE and Shanghai Fosun Pharmaceutical Co., Ltd. jointly announced that their lead mRNA COVID-19 vaccine candidate BNT162b2 would be evaluated in Phase 2 clinical trial Taizhou and Lianshui, Jiangsu Province, China.

November 18, 2020 - Pfizer Inc. and BioNTech SE announced that, after conducting the final efficacy analysis in their ongoing Phase 3 study, their mRNA-based COVID-19 vaccine candidate, BNT162b2, met all of the study’s primary efficacy endpoints.

November 12, 2020 - China’s regulatory authority accepts the mRNA vaccine candidate's Fosun Pharma clinical trial application. The Shanghai-based conglomerate will maintain close communication with regulatory and licensing authorities and hopes ongoing research and testing will show the vaccine complies with Chinese laws and will be available as quickly as possible, wrote Guo. In March 2020, Fosun Pharmaceutical Industrial was granted a German company BioNTech to develop and commercialize its vaccine products exclusively developed based on BioNTech's proprietary mRNA technology platform targeting COVID-19 in China. 

November 9, 2020 - Pfizer Inc. and BioNTech SE announced their mRNA-based vaccine candidate, BNT162b2, against SARS-CoV-2 had demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of SARS-CoV-2 infection, based on the first interim efficacy analysis conducted on November 8, 2020, by an external, independent Data Monitoring Committee from the Phase 3 clinical study.

October 14, 2020 - Australia’s Therapeutic Goods Administration announced Pfizer Australia Pty Ltd. had received provisional 'determination' for its COVID-19 vaccine candidate, BNT162b2. The next step is that Pfizer may now apply for provisional approval.'

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 17, 2020 - BioNTech SE announced signing a share purchase agreement with Novartis AG to acquire its GMP-certified manufacturing facility in Marburg, Germany.

September 15, 2020 - BioNTech SE 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.

August 20, 2020 - A non-peer-reviewed study's conclusion supports selecting the BNT162b2 vaccine candidate for Phase 2/3 large-scale safety and efficacy evaluation.

July 22, 2020 - Pfizer and BioNTech SE 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. 

June 29, 2020 - BioNTech SE announced a private investment of USD 250 million by investors.

April 22, 2020 - Pfizer Inc. and BioNTech SE have entered into a global collaboration agreement to co-develop BioNTech’s potential first-in-class, mRNA-based coronavirus vaccine program to prevent COVID-19 infection.

March 17, 2020 - BioNTech announced details of its efforts to develop a potential vaccine to induce immunity and prevent COVID-19 infection.

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

BioNTech - Pfizer COVID-19 Vaccine Clinical Trials

Pfizer's website displays various clinical trial participant metrics.

Clinical Trials