After a year of several hundred thousand deaths and misery for virtually all Americans, there is good news this December. FDA has granted emergency use approval for one vaccine and another vaccine will be reviewed shortly. While distribution of the vaccines is expected to take months, the promise of these vaccines, and possibly other vaccines, should lift the spirits of everyone.
The approval of the Pfizer-BioNTech COVID-19 Vaccine
On December 11, 2020, the US Food and Drug Administration issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. The emergency use authorization allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the United States.
FDA announced that the authorization of the first COVID-19 vaccine for emergency use is a major milestone in battling the healthcare pandemic that has touched so many US families and families across the world. FDA Commissioner Stephen M. Hahn, M.D said,
“Today’s action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization. The tireless work to develop a new vaccine to prevent this novel, serious, and life-threatening disease in an expedited timeframe after its emergence is a true testament to scientific innovation and public-private collaboration worldwide.”
The December 11 announcement stated that FDA has concluded that the Pfizer-BioNTech COVID-19 Vaccine has met the statutory criteria for issuance of an EUA. FDA added that the “totality of the available data” gives clear evidence that the Pfizer-BioNTech COVID-19 Vaccine “may be effective in preventing COVID-19.”
The data also supports the conclusion that the known and potential benefits of the vaccine outweigh the known and potential risks. This conclusion thus supports the use of the vaccine in millions of people 16 years of age and older, including healthy individuals.
FDA added that, in making its determination, FDA assures the public and the medical community that the agency has “conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information.”
Makers of medical products such as vaccines that promote treatments, diagnostic abilities, or cures that don’t have FDA approval or an FDA EUA are subject to warning letters and other legal actions by the Food and Drug Administration.
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Key components of the Pfizer-BioNTech COVID-19 Vaccine
According to Gilmore Health News, Pfizer’s Covid-19 vaccine is an RNA vaccine that doesn’t require an infectious agent. “The immunogenic properties of RNA were not discovered until the 1990s.”
The Pfizer-BioNTech COVID-19 Vaccine contains a genetic material called messenger RNA (mRNA). The way the vaccine works is that the vaccine “contains a small piece of the SARS-CoV-2 virus’s mRNA that instructs cells in the body to make the virus’s distinctive ‘spike’ protein.”
Messenger RNA vaccines use an injection of a synthetic messenger RNA. “This comprises the sequence of the protein of interest as well as other non-structural proteins that facilitate its translation through the cellular machinery.”
Some of the advantages of messenger RNA vaccines include:
- Production on a large scale at a low cost is possible.
- The dosages of the vaccine are very pure – the doses only contain “the RNA of interest encapsulated in its lipid bubble and nothing else. “
- “Adjuvants do not seem to be necessary to get a satisfactory immune response, because a simple lipid capsule enhances the immunogenic properties of RNAs. mRNAs have a very short half-life and are easily degradable.”
- Another advantage of mRNA is that the vaccines don’t “interact with the genome, and their absorption by cellular machinery occurs exclusively in the cytoplasm, unlike DNA vaccines.”
The drawbacks of mRNA include:
- The technology is relatively new – so there’s not a lot of scientific data on usage.
- “Vaccine RNAs that lose their lipid bubble or are not encapsulated at the time of injection are more likely to be destroyed before they even enter the cells.”
- Some clinical trials have shown serious adverse events.
- mRNA is very fragile. Pfizer stated that the vaccine needs to be stored at -80°C. This means the vaccine can’t be stored in advance and refrigerated. The vaccine generally needs to be stored in vaccination centers which are “capable of storing large amounts of liquid nitrogen vaccine units.”
When someone receives this vaccine, “their body produces copies of the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.”
The vaccine EUA is not an FDA approval. The EUA of the Pfizer-BioNTech COVID-19 Vaccine does have the promise “to alter the course of this pandemic in the United States,” said Peter Marks, M.D., Ph.D., Director of the FDA’s Center for Biologics Evaluation and Research. Dr. Marks added that by using science as the decision-making guide, “the available safety and effectiveness data support the authorization of the Pfizer-BioNTech COVID-19 Vaccine because the vaccine’s known and potential benefits clearly outweigh its known and potential risks. “
The data the sponsor provided met FDA’s expectations – as indicated in FDA’s June and October guidance documents. The work to speed vaccine development hasn’t sacrificed scientific standards or the vaccine evaluation process’s scientific standards.
FDA’s review process
The review process of the vaccine by FDA also included an independent and public review from members of FDA’s Vaccines and Related Biological Products Advisory Committee. The announcement of the EUA for the vaccine, FDA took pride in saying, is “ultimately a testament to the commitment of our career scientists and physicians, who worked tirelessly to thoroughly evaluate the data and information for this vaccine.”
The evaluation of available safety data by the Food and Drug Administration
People who receive the Pfizer BioNTech COVID-19 Vaccine will receive two doses, three weeks apart. The safety data that was available when the FDA made its EUA review included 37,586 participants who enrolled in an ongoing randomized, placebo-controlled international study, the majority of whom were U.S. participants. 18,801 of the participants received the vaccine and 18,785 received a saline placebo. The participants were then followed for a median of two months after receiving the second dose.
The side effects most often reported, which lasted usually for a few days, were “pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, and fever.” FDA noted that more people felt these side effects after the second dose than after the first dose – which means vaccination providers and recipients should expect there may be side effects after either dose -but that side effects are more likely after the second dose.
FDA stated that Pfizer Inc. and vaccination providers are required (it’s mandatory) to
“Report the following to the Vaccine Adverse Event Reporting System (VAERS) for Pfizer-BioNTech COVID-19 Vaccine: all vaccine administration errors, serious adverse events, cases of Multisystem Inflammatory Syndrome (MIS), and cases of COVID-19 that result in hospitalization or death.”
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FDA Evaluation of available effectiveness data
The effectiveness data used to support the issuance of the EUA included an “analysis of 36,523 participants in the ongoing randomized, placebo-controlled international study, the majority of whom are U.S. participants, who did not have evidence of SARS-CoV-2 infection through seven days after the second dose. “
“Among these participants, 18,198 received the vaccine and 18,325 received placebo. The vaccine was 95% effective in preventing COVID-19 disease among these clinical trial participants with eight COVID-19 cases in the vaccine group and 162 in the placebo group. “
Of the total 170 COVID-19 cases, one vaccine participant’s COVID-19 case was classified as severe, and three placebo participant’s COVID-19 cases were classified as severe. FDA stated that the data isn’t available to determine:
- How long the vaccine provides protection for
- If there is evidence the vaccine prevents person-to-person transmission of SARS-CoV-2 from person to person.
How the EUA Process worked
The Secretary for the US Department of Health and Human Services determined on February 4, 2020, that the public health emergency would have a strong potential to affect national security or the health and security of American citizens living abroad. The Secretary issued declarations that there were circumstances that justified emergency use authorization of unapproved drugs – permitting FDA to issue an EUA allowing “unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent COVID-19 when there are no adequate, approved, and available alternatives.”
An EUA is not the same as an FDA approval (licensure) of a vaccine. FDA, when deciding whether to issue an EUA for a product, evaluates the evidence and assesses the risks (known or potential) and the benefits (known or potential). If there is a favorable benefit to risk assessment, the product is “made available during the emergency.”
When a manufacturer submits an EUA request for a COVID-19 vaccine to FDA, the agency reviews the request and determines if the statutory criteria are met, “taking into account the totality of the scientific evidence about the vaccine that is available to the FDA.”
An emergency use authorization also requires that “fact sheets that provide important information, including dosing instructions, and information about the benefits and risks of the Pfizer-BioNTech COVID-19 Vaccine, be made available to vaccination providers and vaccine recipients.”
Pfizer Inc. did submit a pharmacovigilance plan to FDA to monitor the safety of Pfizer-BioNTech COVID-19 Vaccine. This plan includes a plan to provide long-term safety follow-up for the participants who agreed to enroll in the ongoing clinical trials. The plan also includes other safety monitoring activities of the Pfizer-BioNTech COVID-19 vaccine “and ensuring that any safety concerns are identified and evaluated in a timely manner.”
FDA anticipates that manufacturers whose COVID-19 vaccines are approved under an EUA to continue their clinical trials so that the manufacturers can obtain more safety and effectiveness information – and pursue formal FDA approval (licensure).
The EUA for the Pfizer-BioNTech COVID-19 Vaccine was issued to Pfizer Inc. The EUA will be effective:
“Until the declaration that there are circumstances which just an EUA of drugs and biologics to help prevent and treat CoVID-19 is terminated. The EUA may be revised or revoked if the statutory criteria for issuance of the EA are no longer satisfied.”
FDA is a US Department of Health and Human Services agency which protects the health of the public “by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.” FDA is also responsible for the “safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.”
Good news. FDA has given an emergency use authorization to a COVID-19 vaccine developed by Pfizer Inc. The EUA was approved after review by an FDA advisory panel of experts of Pfizer’s clinical trials which included two groups – one that was given the vaccine and the other which was given a saline placebo.
Medical product and device manufacturers and healthcare practitioners should contact Cohen Healthcare Law Group, PC for legal advice on emergency use authorization and the full range of FDA compliance issues. Our experienced healthcare lawyers have helped numerous medical companies and providers understand and respond to their compliance issues.