Vaccine Breaking News

Vaccine breaking news brought to you by Precision Vaccinations.

Jul 24, 2021 • 11:59 am CDT

A non-peer-reviewed study's findings indicate that SARS-CoV-2 neutralizing antibodies (NAbs) titer elicited by the CoronaVac vaccine are much lower when compared to natural infection protection against the new coronavirus variants.

Since SARS-CoV-2 was confirmed in 2019, it has mutated many times, leading to the emergence of various virus variants referred to as variants of concern (VOCs).

Published on July 15, 2021, this study evaluated CoronaVac's effectiveness against the B.1.1.7 (Alpha), B.1.351 (Beta), and B.1.617.2 (Delta) strains in Thailand.

The researchers found that, despite equally robust production of S1-RBD-binding IgG and 100% seropositivity, sera from both CoronaVac vaccinees and naturally infected individuals had significantly reduced neutralizing capacity against all three variants.

While the NAb titers against Alpha and Beta were comparable, the Delta variant appears to be significantly more refractory to NAbs in all groups.

These results may help inform on CoronaVac NAb-inducing capacity, which is a proxy for vaccine efficacy. These results also have critical implications for public health decision-makers who may need to maintain efficient mitigation strategies amid a potentially high risk for re-infection, even in those people who have been previously infected.

CoronaVac is a 2-dose β-propiolactone-inactivated, aluminum hydroxide-adjuvanted COVID-19 vaccine administered on a 0/14-28-day schedule to prevent COVID-19 disease.

Note: Preliminary scientific reports are not peer-reviewed and should not be regarded as conclusive guide clinical practice or health-related behavior.

Jul 24, 2021 • 11:18 am CDT

The COVID-19 pandemic and the implementation of nonpharmaceutical interventions (physical distancing, staying home) reduced the transmission of some viral respiratory pathogens such as influenza viruses, stated the U.S. CDC report issued on July 23, 2021.

In the USA, influenza activity initially decreased in March 2020, was historically low infection rates reported through the summer of 2020.

From October 3, 2020–May 22, 2021, influenza activity was lower than during any previous flu season since 1997, the first season for which data are publicly available, says the CDC.

Furthermore, the 2021-2022 influenza season is expected to begin in the fall, with many unanswerable questions. Such as when should people get their flu shot? Should flu shots and COVID-19 vaccines be co-administered? 

The CDC says 'Clinicians should be aware of increased circulation, sometimes offseason, of some respiratory viruses and consider multi pathogen testing. In addition to recommended preventive actions, fall influenza vaccination campaigns are important as schools and workplaces resume in-person activities with relaxed COVID-19 mitigation practices.'

'Clinicians should be aware that respiratory viruses might not exhibit typical seasonal circulation patterns and that a resumption of circulation of certain respiratory viruses is occurring. Therefore, an increased index of suspicion and testing for multiple respiratory pathogens remain important,' stated the CDC.

Most people over 6-months of age are encouraged to get vaccinated every flu season since influenza infections can create severe consequences, said the CDC.

The most common flu shot in the Northern Hemisphere are quadrivalent vaccines that protect people against four viruses: influenza A (H1N1) virus, influenza A (H3N2) virus, and two influenza B viruses, said the CDC.

The flu CDC report is available on this weblink. Corresponding authors: Sonja Olsen, [email protected]; Amber Winn, [email protected].

Jul 24, 2021 • 8:05 am CDT

India's Ministry of Health and Family Welfare issued an alert on July 21, 2021, confirming the first documented case of bird flu in humans in India. The child was diagnosed in June 2021 at the Department of Pediatrics, AIIMS, Delhi. 

Soon after the induction therapy, the 11-year-old boy developed fever, cough, cold, and shortness of breath. AML was diagnosed with febrile neutropenia, pneumonia that progressed to ARDS. He was admitted to AIIMS on July 2, 2021. Unfortunately, several organs of the child stopped functioning, and he died on July 12th.

The Animal Husbandry Department has not found any suspected cases of bird flu in the area, and as a precautionary measure, surveillance has been increased in the 10 km area.

The WHO says Zoonotic influenza refers to diseases caused by animal influenza viruses, such as Bird Flu and Swine Flu. Even though Bird Flu and Swine Flu viruses are found in humans, these animal viruses are distinct from human influenza viruses. 

Bird Flu (Avian Influenza) is the disease caused by influenza type A viruses in animals. These viruses occur naturally among birds and domestic poultry. 

The annual 'flu shot' does not prevent Zoonotic influenza infections, says the U.S. CDC. However, vaccines to protect against 2009 H1N1 are available in the USA.

Previous Zoonotic influenza news is published on this webpage.

Jul 23, 2021 • 3:19 pm CDT

'We have what it takes to finally wipe polio off the face of the earth. The Global Polio Eradication Initiative (GPEI), a public-private partnership that includes our foundation, has proven it can meet local challenges to eliminate polio in country after country,' wrote Bill Gates in the GatesNotes posting on July 20, 2021.

The GPEI initiative focuses on adopting new tools and approaches to make vaccination campaigns more effective to protect every child. And, most importantly, we have thousands of dedicated polio workers committed to this case.

Unfortunately, polio cases continue to be reported by various countries.

The World Health Organization reported 1,226 cases of all forms of polio were recorded during 2020, compared to 138 in 2018. 

And as of July 21, 2021, the GPEI reported a summary of new WPV and cVDPV viruses this week (AFP cases and ES positives):

  • Ethiopia: 10 cVDPV2 cases and one cVDPV2 positive environmental sample
  • Liberia: one cVDPV2 case
  • Madagascar: two cVDPV1 cases
  • Nigeria: nine cVDPV2 cases and five cVDPV2 positive environmental samples
  • Senegal: one cVDPV2 case
  • South Sudan: one cVDPV2 case

Polio, or poliomyelitis, is a disabling and life-threatening disease caused by the poliovirus. The virus spreads from person to person and can infect a person’s spinal cord, causing paralysis, says the U.S. CDC's website.

Following the introduction of polio vaccines, specifically, trivalent inactivated poliovirus vaccine (IPV) in 1955, followed by the trivalent oral poliovirus vaccine (OPV) in 1963, the number of polio cases in the USA fell rapidly to fewer than 10 in the 1970s.

For the best protection, children should get four doses of the polio vaccine. This vaccine is given as a shot in the arm or leg and is very safe, says the CDC. The inactivated polio vaccine may sometimes be given simultaneously as other vaccines, so discuss this option with your healthcare provider.

For information about adults who may not have received sufficient vaccine protection, see the CDC's adult polio vaccination schedule.

Getting the recommended doses of the polio vaccine is an important part of eliminating polio forever!

Jul 23, 2021 • 2:48 pm CDT

The London School of Hygiene & Tropical Medicine (LSHTM) stated in a press statement issued on July 20, 2021, introducing the pneumococcal conjugate vaccine (PCV) to childhood routine vaccination in The Republic of Gambia reduced severe infections associated with pneumococcal disease.'

The Gambia introduced a seven-valent pneumococcal conjugate vaccine (PCV7) in August 2009, followed by PCV13 in May 2011, using a schedule of three primary doses without a booster dose or catch-up immunization.

According to research published in The Lancet Infectious Diseases on July 16, 2021, the Pneumococcal Surveillance Project (PSP) showed that, among children aged 2-59 months, the use of PCV in The Gambia reduced the incidence of severe pneumococcal pneumonia, sepsis, and meningitis in children by 80%.

The introduction of the PVC was also found to reduce very severe pneumonia by 60%, and zero cases of the vaccine-type invasive pneumococcal disease were detected in the 2-11 month age group from 2016 to 2017.

The study was carried out in collaboration with the MRC Unit The Gambia at the LSHTM, Ministry of Health in The Gambia, Medical Research Council (MRC), University of Otago, International Vaccine Access Centre at Johns Hopkins University, Murdoch Children’s Research Institute in Melbourne, and the Program for Appropriate Technology in Health in Seattle.

This new study also found that radiological pneumonia decreased by 33% in the 2-29-month-olds, while pneumonia hospitalizations declined by 27%. In older children aged 5-14 years, invasive pneumococcal disease cases declined by 69% and radiological pneumonia by 27%.

These researchers hope the study's findings will bolster confidence in countries that have introduced PCV into their vaccination programs and encourage countries that have not yet adopted this life-saving vaccine to do so.

The researchers acknowledge the limitations of this study, including low proportions of children who received at least two doses for several months after vaccine introduction.

The PSP was funded by the Global Alliance for Vaccines, the Immunisation’s Pneumococcal Vaccines Accelerated Development and Introduction Programme, the Bill & Melinda Gates Foundation, Pfizer Ltd., and the MRC. In addition, researcher conflicts of interest were disclosed.

Note: The Gambia is one of the smallest and most densely populated countries on mainland Africa, with an extent of about 330 km east to west and less than 50 km north to south. 

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Jul 23, 2021 • 1:20 pm CDT

'The United States once again sees a rise in COVID-19 cases, hospitalizations, and deaths. As of July 22, 2021, COVID-19 cases are on the rise in nearly 90% of U.S. jurisdictions,' stated the U.S. CDC's website weekly statement.

COVID-19 is now a preventable disease, and when you are fully vaccinated, you are protected against severe illness, hospitalization, and death, says the CDC.

The U.S. COVID-19 Vaccination Program began December 14, 2020. Since then, the U.S. FDA has issued three emergency authorizations for experimental COVID-19 vaccines.

Overall, about 187 million people, or 56.4% of the total U.S. population, have received at least one dose of a COVID-19 vaccine. And 79.6% of people ages 65+ are fully vaccinated.

However, as of July 22nd, the 7-day average number of administered vaccine doses reported to CDC per day was a 35.2% decrease from the previous week.

Note: On July 22, 2021, U.S. CDC's Advisory Committee on Immunization Practices held a digital meeting. The related agenda and presentations are hyperlinked.

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Jul 23, 2021 • 10:13 am CDT

The European Medicines Agency (EMA) announced its human medicines committee (CHMP) has recommended granting an extension of indication for the COVID-19 vaccine Spikevax (previously Moderna) to include use in adolescents aged 12 to 17 years.

The SpikeVax vaccine was authorized for use in people aged 18 and above in early 2021.

Spikevax works by preparing the body to defend itself against COVID-19. It contains a molecule called messenger RNA (mRNA), which has instructions for making the spike protein. This is a protein on the surface of the SARS-CoV-2 virus, which the virus needs to enter the body’s cells.

The vaccine efficacy of Spikevax has been investigated in a study involving 3,732 adolescents aged 12 to 17 years. 

The study showed that Spikevax produced a comparable antibody response in 12- to 17-year-olds to that seen in young adults aged 18 to 25 years. In addition, none of 2,163 children receiving the vaccine developed COVID-19 compared with only four of 1,073 children given a placebo injection.

The CHMP noted that due to the limited number of adolescents included in the study, it could not have detected new uncommon side effects or estimated the risk of known side effects such as myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane around the heart).

The UK's Medicines and Healthcare products Regulatory Agency reported on July 14, 2021, there have been 17 reports of myocarditis, 20 reports of pericarditis following the use of COVID-19 Vaccine Moderna.

However, the overall safety profile of Spikevax determined in adults was confirmed in the adolescent study. Therefore, the CHMP considered that the benefits of Spikevax in adolescents outweigh the risks, particularly those with conditions that increase the risk of severe COVID-19.

The safety and efficacy of this COVID-19 vaccine in both adolescents and adults will continue to be monitored across the Member States through the EU pharmacovigilance system and ongoing and additional studies by the company and by European authorities.

The European Medicines Agency is a decentralized agency of the European Union (EU) responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the EU.

Jul 23, 2021 • 6:18 am CDT

Pfizer Inc. and BioNTech SE today announced that the U.S. government had purchased an additional 200 million doses of the Pfizer-BioNTech COVID-19 Vaccine (Comirnaty).

These vaccine doses are expected to be delivered from October 2021 through April 2022.

This purchase brings the total number of doses to be supplied by the companies to the U.S. government under its existing supply agreement to 500 million.

In a previous, separate announcement on June 10, 2021, Pfizer and BioNTech shared plans to provide the U.S. government with 500 million doses of the companies’ COVID-19 vaccine for donation to the world’s poorest nations.

“It has been our consistent goal to supply as many doses of our COVID-19 vaccine as possible to people around the world to help bring an end to this pandemic,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “We are honored to support the U.S. and more than 100 countries in their continuing vaccination programs.”

The companies expect to deliver 110 million of the additional doses by December 31, 2021, with the remaining 90 million doses to be delivered no later than April 30, 2022. The U.S. government also has the option to acquire an updated version of the vaccine to address potential variants and new formulations of the vaccine, if available and authorized.

The Pfizer-BioNTech COVID-19 Vaccine (Comirnaty) has not been approved or licensed by the U.S. Food and Drug Administration (FDA). Still, the FDA has authorized emergency use under an Emergency Use Authorization to prevent COVID-19 caused by the SARS-CoV-2 coronavirus for use in individuals 12 years of age and older.

Jul 22, 2021 • 1:40 pm CDT

The United Kingdom Medicines & Healthcare Regulatory Agency (MHRA) announced on July 22, 2021, it had received additional Yellow Card reports of suspected adverse drug reactions (ADR) related to COVID-19 vaccinations in which the patient died shortly after vaccination.

Three COVID-19 vaccines, Pfizer-BioNTech, COVID-19 Vaccine AstraZeneca, and COVID-19 Vaccine Moderna, are currently being used in the UK. 

Data from the UK Public Health agencies indicate that at least 46 million people have received their first vaccination in the UK by July 14th, with 35 million second doses administered.

As of July 14, 2021, the MHRA has received 460 UK reports of suspected ADRs to the Pfizer-BioNTech (Comirnaty) vaccine, in which the patient died shortly after vaccination.

Additionally, 999 reports for the COVID-19 Vaccine AstraZeneca (Vaxzevria) and 7 for the COVID-19 Vaccine Moderna (SpikeVax) were reported.

‘The majority of these Yellow Card reports in the UK were in older people, or people with underlying illnesses’ wrote the MHRA. ‘Usage of the vaccines has increased throughout campaigns. As such, so has reported fatal events with a temporal association with vaccination.’

‘However, this does not indicate a link between vaccination and the fatalities reported.’ 

‘Review of individual reports and patterns of reporting does not suggest the vaccines played a role in these deaths.’

'As with any vaccine, the COVID-19 vaccines will cause side effects in some people. The total number and the nature of Yellow Cards reported so far is not unusual for a new vaccine for which members of the public and healthcare professionals are encouraged to report any suspected adverse reaction' says the MHRA.

In addition, the UK’s MHRA had received ADR related to heart inflammation cases as of July 14, 2021.

The MHRA received 112 reports of myocarditis and 103 reports of pericarditis following Pfizer - BioNTech (Comirnaty) vaccination and one report each of viral pericarditis, infective pericarditis, and Streptococcal endocarditis. 

For the COVID-19 Vaccine AstraZeneca (Vaxzevria), 76 reports of myocarditis and 126 reports of pericarditis, and four reports for viral pericarditis have been reported endocarditis, two reports for endocarditis bacterial, and one report each for viral myocarditis and infectious myocarditis. 

And there have been 17 reports of myocarditis, 20 reports of pericarditis, and one report of endocarditis following the use of COVID-19 Vaccine Moderna (SpikeVax) up to the same date.

The UK says, ‘Myocarditis and pericarditis happen very rarely in the general population, and it is estimated that in the UK, there are about six new cases of myocarditis per 100,000 patients per year and about ten new cases of pericarditis per 100,000 patients per year.’

On July 9, 2021, the European Medicines Agency announced its safety committee had concluded that myocarditis and pericarditis could occur in very rare cases following vaccination with the COVID-19 vaccines Comirnaty and Spikevax.'

The MHRA report continued to say, 'Vaccines are the best way to protect people from COVID-19 and have already saved thousands of lives. Everyone should continue to get their vaccination when asked to do so unless specifically advised otherwise.'

The MHRA operates the Yellow Card scheme on behalf of the Commission on Human Medicines. The scheme collects and monitors suspected safety concerns or incidents involving vaccines, medicines, medical devices, and e-cigarettes.

The UK’s Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices, and blood components for transfusion in the UK. It is an executive agency sponsored by the Department of Health and Social Care.

Note: The UK’s Joint Committee on Vaccination and Immunisation (JCVI) confirmed on July 19, 2021, the JCVI advises that children at increased risk of serious COVID-19 disease are offered the Pfizer-BioNTech (Comirnaty) 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 should be offered the vaccine. This is to indirectly protect their immunosuppressed household contacts, who are at higher risk of serious disease from COVID-19 and may not generate a full immune response to vaccination. However, the JCVI is not currently advising routine vaccination of children outside these groups, based on the current evidence.

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Jul 22, 2021 • 9:40 am CDT

This report issued by the UK government issued on July 22, 2021, summarises the information from the surveillance systems which are used to monitor influenza and other seasonal respiratory viruses in England. The report is based on data from week #28.

Through Respiratory Datamart, there were no influenza-positive samples detected in week #28 in England between July 12 up to July 20th.

And other indicators for influenza such as hospital admissions and GP Influenza-like Illness (ILI) consultation rates remain low.

Rhinovirus activity decreased slightly to 10.2%, and adenovirus and human metapneumovirus (hMPV) positivity remained low at 1.1% and 0.7%, respectively, with arainfluenza positivity decreasing from 8.7% to 7.0% in week #28.

However, Respiratory Syncytial Virus positivity increased from 6.8% to 8.9%.

Additionally, FluSurvey, a web tool survey designed to monitor trends of ILI in the UK's community using self-reported respiratory symptoms from registered participants.

A total of 2,693 participants completed the weekly survey in week #28, of which (2.7%) reported fever or cough and (0.8% reported ILI. The most commonly used healthcare service reported by FluSurvey respondents remains telehealth, a GP practice in England.

Note: On June 10, 2021, the U.S. CDC published a Health Advisory to notify clinicians and caregivers about increased interseasonal RSV activity across parts of the Southern United States. Due to this increased activity, CDC encourages broader testing for RSV among patients presenting with acute respiratory illness who test negative for the SARS-CoV-2 coronavirus. RSV can be associated with severe disease in young children and older adults.

Jul 22, 2021 • 6:41 am CDT

The U.S. CDC's Advisory Committee on Immunization Practices (ACIP) finalized the agenda for the digital meeting scheduled for July 22, 2021, from 11 am to 4 pm ET. The topics include:

  • Guillain-Barré Syndrome (GBS) after Janssen COVID-19 vaccine: Vaccine Adverse Event Reporting System Guillain-Barré Syndrome (GBS) after Janssen COVID-19 vaccine: Vaccine Safety Datalink (VSD) VaST assessment of GBS after Janssen COVID-19 vaccine Discussion,
  • COVID-19 vaccines: benefits-risk discussion Work Group interpretation and next steps.

Registration is not required to watch the live, no-cost ACIP meeting webcast.

The ACIP provides advice and guidance to Dr. Rochelle Paula Walensky, the Director of the CDC, regarding the use of vaccines and related agents to control vaccine-preventable diseases in the civilian population of the USA. The CDC Director reviews recommendations made by the ACIP and, if adopted, are published as official CDC/HHS recommendations in the Morbidity and Mortality Weekly Report.

Previous ACIP meeting presentations are rendered on this CDC webpage.

Note: Dr. Jose R. Romero, ACIP Chair, clarified at 11:10 AM CT that this ACIP meeting would NOT be discussing reports of myocarditis or pericarditis, vaccine-related fatalities, or vaccine efficacy data from international sources.

Jul 22, 2021 • 6:10 am CDT

A national research study has been launched in Canada to investigate the effectiveness and safety of COVID-19 vaccines in transplant recipients. Through its COVID-19 Immunity Task Force (CITF) and Vaccine Surveillance Reference Group (VSRG), the Government of Canada announced on July 22, 2021, that it is investing over $2.84 million in this research study.

This effort is based at University Health Network and called PREVenT COVID, short for Prospective Evaluation of COVID-19 Vaccine in Transplant Recipients: A National Strategy.

“Because people who have received a solid organ transplant and other immunosuppressed individuals are generally excluded from clinical trials of vaccines, little data exists to guide clinical best practices for these populations,” commented Dr. Deepali Kumar, project lead, Clinician Investigator at the Toronto General Hospital Research Institute and Director of Transplant Infectious Diseases at the Ajmera Transplant Centre, in a related press statement.

“Our research will address this knowledge gap by revealing how transplant recipients—who are on immune-suppressing medications to prevent organ rejection—respond to COVID-19 vaccines."

"We will compare their immune responses to non-transplanted individuals as well as those who have contracted COVID-19," said Dr. Kumar.

With this funding, Dr. Kumar’s team intends to focus on multiple transplant centers to examine short- and long-term antibody responses in transplant recipients following first and second doses of COVID-19 vaccines.

The research team will compare these responses to healthy individuals who have not undergone transplants and transplant recipients who naturally contracted COVID-19.

The Government of Canada established the COVID-19 Immunity Task Force in late April 2020.

In January 2021, Canada established an Expert Panel (report) to identify the key knowledge gaps related to research on vaccination in recipients and then held a follow-up Workshop (view this report) with approximately 40 stakeholder organizations to prioritize, align, and begin planning studies. On April 23, 2021, a second National Workshop focused on communication of vaccination research with transplant patients and families (report forthcoming).

The Task Force is overseen by a Leadership Group of volunteers that includes leading Canadian scientists and experts from universities and healthcare facilities across Canada who are focused on understanding the nature of immunity arising from the novel coronavirus that causes COVID-19. 

Note: Only vaccines proven to be safe, effective, and of high quality are Authorized for use in Canada, says the government's website. As of July 16, 2021, the following COVID-19 vaccines are available in Canada: Comirnaty, CoviShield, Janssen, and SpikeVax. The list of drugs and vaccine applications received by the Canadian government is found on this webpage.

Jul 21, 2021 • 8:11 pm CDT

California-based Sorrento Therapeutics, Inc. announced today that COVID-19 patients had been dosed in its Phase 2 efficacy trial. Approximately 350 outpatients with COVID-19 who are asymptomatic or have mild symptoms will be enrolled in this large double-blind, randomized clinical trial evaluating COVIDROPS doses of 10 mg or 20 mg against placebo.

COVIDROPS is administered as a simple intranasal dose into each nostril to recently infected subjects.

This clinical study uses a novel decentralized design where subjects are assessed and treated in their homes and received a rapid review and clearance from the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.

A previously completed safety study conducted in the US at doses up to 60 mg in healthy subjects showed a comparable safety profile to placebo, with all reported adverse effects being mild in severity.

The UK study will complement Phase 2 trials currently being started in the USA, and should the results of these studies demonstrate that COVIDROPS is both safe and effective against SARS-CoV-2, Sorrento will apply for Emergency Use Authorization in the USA, UK, Canada, India, Mexico, and European Union as well as other territories.

The neutralizing antibody drug substance is the same antibody as in COVI-AMG, a high potency/low dose IV push injection.

The antibody is active in vitro and animal models of COVID-19 infection against certain SARS-CoV-2 variants of concern.

Sorrento is a clinical-stage, antibody-centric biopharmaceutical company developing new therapies to treat cancers and COVID-19.

Jul 21, 2021 • 6:43 pm CDT

The U.S. CDC's website reported at 6:30 PM CT on July 21, 2021, the Vaccine Adverse Event Reporting System (VAERS) had received 6,207 reports of death (0.0018%) about people who received a COVID-19 vaccine.

However, reports of adverse events submitted to VAERS following vaccination, including deaths, do not necessarily mean that a vaccine caused a health problem. A review of available clinical information, including death certificates, autopsy, and medical records, has not established a causal link to COVID-19 vaccines, says the Centers for Disease Control and Prevention (CDC).

This CDC data is based on more than 339 million COVID-19 vaccines administered in the USA from December 14, 2020, through July 19, 2021.

As of July 21, 2021, the U.S. Food and Drug Administration (FDA) had issued three Emergency Use Authorizations for COVID-19 vaccines. The FDA has not Approved any experimental COVID-19 vaccine.

Established in 1990, the VAERS is a national early warning system co-managed by the CDC and the FDA. VAERS accepts and analyzes reports of adverse events after a person has received a vaccination.

Anyone can report an adverse event to VAERS. Healthcare professionals are required to report certain adverse events, and vaccine manufacturers are required to report all adverse events that come to their attention.

However, VAERS is a passive reporting system, meaning it relies on individuals to send in reports of their experiences to the CDC and FDA. VAERS is not designed to determine if a vaccine caused a health problem. But it is especially useful for detecting unusual or unexpected patterns of adverse event reporting that might indicate a possible safety problem with a vaccine, says the U.S. government.

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Jul 21, 2021 • 3:51 pm CDT

Pfizer Inc. and Germany-based BioNTech SE announced today the signing of a letter of intent with The Biovac Institute (Pty) Ltd, known as “Biovac,” a South African biopharmaceutical company, to manufacture the Pfizer-BioNTech COVID-19 (Comirnaty) vaccine for distribution within the African Union.

The press statement says, 'To facilitate Biovac’s involvement in the process, technical transfer, on-site development, and equipment installation activities will begin immediately.'

Pfizer and BioNTech expect that Biovac’s Cape Town facility will be incorporated into the vaccine supply chain by the end of 2021.

Biovac will obtain drug substance from facilities in Europe, and manufacturing of finished doses will commence in 2022. At full operational capacity, the annual production will exceed 100 million finished doses annually. All doses will exclusively be distributed within the 55 member states that make up the African Union.

“From day one, our goal has been to provide fair and equitable access of the Pfizer-BioNTech COVID-19 vaccine to everyone, everywhere,” commented Albert Bourla, Chairman and CEO, Pfizer, in the July 21, 2021 press release.

“We are thrilled to collaborate with Pfizer and BioNTech to produce and distribute the Pfizer-BioNTech COVID-19 vaccine within Africa. This is a testament to the long-standing relationship we have had with Pfizer through the Prevenar 13 vaccine,” added Dr. Morena Makhoana, CEO of Biovac.

Pfizer and Biovac have worked together since 2015 on the sterile formulation, fill, finish, and distribution of the Prevenar 13 vaccine.

To date, Pfizer and BioNTech have shipped more than 1 billion COVID-19 vaccine doses to more than 100 countries or territories in every region of the world.

The companies are firmly committed to working towards equitable and affordable access for COVID-19 vaccines for all people around the world, actively working with global governments as well as global health partners with the aim to provide 2 billion doses too low and middle-income countries in 2021 and 2022 – 1 billion each year.

This includes an agreement to supply 500 million doses to the U.S. Government at a not-for-profit price, that the government will, in turn, donate to the African Union and the COVAX 92 Advanced Market Commitment (AMC) countries, as well as a direct supply agreement with the COVAX facility for 40 million doses.

The Pfizer-BioNTech COVID-19 vaccine, based on BioNTech’s proprietary mRNA technology, was developed by BioNTech and Pfizer.

BioNTech is the Marketing Authorization Holder in the European Union and the holder of emergency use authorizations or equivalent in the United States (jointly with Pfizer), Canada, and other countries in advance of a planned application for full marketing authorizations in these countries.

The Pfizer-BioNTech (Comirnaty) COVID-19 vaccine has not been Approved or licensed by the U.S. Food and Drug Administration (FDA). Still, it has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent COVID-19 caused by the SARS-CoV-2 beta coronavirus for use in individuals 12 years of age and older. The emergency use of this product is only Authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

Please see the Full EUA Prescribing Information available at

Biovac was established in 2003 to revive local human vaccine production in Southern Africa. Alongside the development of the local vaccine industry, through steep investment in local skills and modern facilities, the company has secured high-profile technology transfers from international pharmaceutical companies, including Pfizer and Sanofi Pasteur, to manufacture pediatric vaccines. The company currently supplies a comprehensive range of vaccines supporting the South African Department of Health’s Expanded Programme for Immunisation.