FDA First COVID-19 Vaccine Approval Comirnaty August 23, 2021

Link: https://www.fda.gov/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine

Approval Letter

Package Insert

FAQ for Comirnaty (COVID-19 Vaccine mRNA)

Press Release: https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine

Indication and Approval: The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.” 

According to FDA “Comirnaty contains messenger RNA (mRNA), a kind of genetic material, used by the body to make a mimic of one of the proteins in the virus that causes COVID-19.” “The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into – nor does it alter – an individual’s genetic material.” Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart. 

“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research. “We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.”

Emergency Use Authorization vs. Approval and Other Key Terminology

Following Pfizer BioNTech’s Biologics License application, Moderna filed a Biologics License application. Currently Pfizer BioNTech and Moderna were granted Emergency Use Authorization Status.

Understanding the Regulatory Terminology of Potential Preventions and Treatments for COVID-19

See links or read below.

https://www.fda.gov/consumers/consumer-updates/understanding-regulatory-terminology-potential-preventions-and-treatments-covid-19

https://www.fda.gov/media/138490/download

“There’s a lot of confusion about which medical products might work to prevent or treat coronavirus disease 2019 (COVID-19). Scientists are working hard to develop a number of potential drugs for the prevention or treatment of coronavirus.The FDA recently approved the first treatment for COVID-19, the antiviral drug remdesivir. Some other investigational drugs are already in clinical trials. In some cases, scientists are testing whether drugs that are already approved for a different disease are safe and effective against COVID-19.As studies continue, these drugs are sometimes made available to patients through the FDA’s Expanded Access Program, or under an Emergency Use Authorization. Health care providers may also decide to treat a patient with a drug that has been approved by the FDA for one use, but not for the patient’s disease or condition (sometimes called “off-label” use).If you think you have, or have had, COVID-19, your health care provider has a complete picture of your health and health history and can help you make the best decisions for your care.The language used to describe potential therapies can be confusing, and there’s public interest around the FDA’s work to ensure access to potentially life-saving treatments. Here’s what those terms mean.

What “FDA Approved” Means

U.S. consumers rely on the FDA to provide independent scientific reviews of medical products, including drugs and vaccines. During this public health emergency, there is an urgent need for products to treat or prevent the virus that causes COVID-19. Before the FDA can approve a drug, the agency must determine whether the clinical data and other information show that the drug is safe and effective for its intended use (for example, to prevent or treat a certain disease), and that the product can be made according to federal quality standards.When the FDA approves a drug, it means the agency has determined, based on substantial evidence, that the drug is effective for its intended use, and that the benefits of the drug outweigh its risks when used according to the product’s approved labeling.The FDA is working with manufacturers and researchers to make sure the agency is getting the information needed to complete that evaluation for drugs to treat or prevent COVID-19 as quickly as possible.

Investigational Treatments

An investigational drug can also be called an experimental drug. Scientists conduct clinical trials to study investigational drugs to see if they can safely and effectively prevent or treat a specific disease or condition. As part of those clinical trials, they might try to discover:

  • How the drug might be used for that disease or condition.
  • If the drug is safe for people.
  • How much of the drug is needed. 
  • Information about whether it works against the disease and the potential benefits and risks of taking the drug.

Expanded Access

Sometimes called “compassionate use,” expanded access is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational medical product (drug, biological product, or medical device) for treatment outside of clinical trials when there is no comparable or satisfactory alternative therapy.

Currently, expanded access is one pathway for use of COVID-19 convalescent plasma for patients with serious or immediately life-threatening COVID-19 disease who are not eligible for or who are unable to participate in randomized clinical trials.

Limited information suggests that convalescent plasma – an antibody-rich product made from blood donated by people who have recovered from the virus – may help COVID-19 patients. Because current information is limited, it’s important to evaluate this therapy in the context of a clinical trial.

Emergency Use Authorization (EUA)

An Emergency Use Authorization (EUA) is one of several tools the FDA is using to help make certain medical products available quickly during the COVID-19 pandemic. In certain emergencies, the FDA can issue an EUA to provide access to medical products that may potentially be used when there are no adequate, approved, and available options.

The EUA process is different than an FDA approval or clearance. Under an EUA, in an emergency, the FDA makes a product available to the public based on the best available evidence, without waiting for all the evidence that would be needed for FDA approval or clearance.

When evaluating an EUA, we carefully balance the potential risks and benefits of the products based on the data currently available. 

EUAs are effective until the emergency declaration ends. EUAs can also be revised or revoked by the FDA at any time as we continue to evaluate the available data and patient needs during the public health emergency.

The FDA has granted EUAs to a few possible COVID-19 therapies. Learn more about EUAs in this videoExternal Link Disclaimer.

“Off-Label” Use: Unapproved Uses of Approved Drugs

Once the FDA has approved a drug for a disease or medical condition, health care providers generally may prescribe or administer the drug in clinical practice for an unapproved use not described in the approved labeling (i.e., “off-label”) based on their medical judgment, recognizing that the FDA has not assessed the safety or effectiveness of such use.”

CDC Panel Recommends J&J Restart of COVID-19 Vaccine

https://www.cdc.gov/vaccines/acip/index.html

The committee voted 10 to 4 to recommend use of the vaccine, with one abstention.

Meeting convened on April 23 and link above contains presentation slides.

NOTE: CDC Panel Members proposed that the FDA include a warning label that in rare cases the vaccine has caused clotting in women under 50.

FDA Emergency Use Authorization

https://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-third-covid-19-vaccine

FDA Press Release

For Immediate Release:February 27, 2021

On Feb. 27 the U.S. Food and Drug Administration issued an #emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The EUA allows the Janssen COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older.

“The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States,” said Acting FDA Commissioner Janet Woodcock, M.D. “The FDA, through our open and transparent scientific review process, has now authorized three COVID-19 vaccines with the urgency called for during this pandemic, using the agency’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization.”

The FDA has determined that the Janssen COVID-19 Vaccine has met the statutory criteria for issuance of an EUA. The totality of the available data provides clear evidence that the Janssen COVID-19 Vaccine may be effective in preventing COVID-19. The data also show that the vaccine’s known and potential benefits outweigh its known and potential risks, supporting the company’s request for the vaccine’s use in people 18 years of age and older. In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information.

The Janssen COVID-19 Vaccine is manufactured using a specific type of virus called adenovirus type 26 (Ad26). The vaccine uses Ad26 to deliver a piece of the DNA, or genetic material, that is used to make the distinctive “spike” protein of the SARS-CoV-2 virus. While adenoviruses are a group of viruses that are relatively common, Ad26, which can cause cold symptoms and pink eye, has been modified for the vaccine so that it cannot replicate in the human body to cause illness. After a person receives this vaccine, the body can temporarily make 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.

“After a thorough analysis of the data, the FDA’s scientists and physicians have determined that the vaccine meets the FDA’s expectations for safety and effectiveness appropriate for the authorization of a vaccine for emergency use,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “With today’s authorization, we are adding another vaccine in our medical toolbox to fight this virus. At the same time, the American people can be assured of the FDA’s unwavering commitment to public health through our comprehensive and rigorous evaluation of the data submitted for vaccines to prevent COVID-19.”

FDA Evaluation of Available Safety Data

The Janssen COVID-19 Vaccine is administered as a single dose. The available safety data to support the EUA include an analysis of 43,783 participants enrolled in an ongoing randomized, placebo-controlled study being conducted in South Africa, certain countries in South America, Mexico, and the U.S. The participants, 21,895 of whom received the vaccine and 21,888 of whom received saline placebo, were followed for a median of eight weeks after vaccination. The most commonly reported side effects were pain at the injection site, headache, fatigue, muscle aches and nausea. Most of these side effects were mild to moderate in severity and lasted 1-2 days.

As part of the authorization, the FDA notes that it is mandatory for Janssen Biotech Inc. and vaccination providers to report the following to the Vaccine Adverse Event Reporting System (VAERS) for Janssen COVID-19 Vaccine: serious adverse events, cases of Multisystem Inflammatory Syndrome and cases of COVID-19 that result in hospitalization or death. 

It is also mandatory for vaccination providers to report all vaccine administration errors to VAERS for which they become aware and for Janssen Biotech Inc. to include a summary and analysis of all identified vaccine administration errors in monthly safety reports submitted to the FDA.

#COVID-19 Update: #FDA Advisory Committee Meeting for Possible #Emergency Authorization #Janssen Biotech Inc.’s COVID-19 Vaccine

FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC)to consider request by Janssen Biotech Inc.’s division of J&J. According to Acting FDA Commissioner Janet Woodcock, M.D.

 “A public discussion by the advisory committee members about the data submitted in support of safety and effectiveness of Janssen Biotech Inc.’s COVID-19 vaccine will help ensure that the public has a clear understanding of the scientific data and information that FDA will evaluate in order to make a decision about whether to authorize this vaccine,” “The FDA remains committed to keeping the public informed about our evaluation of the data for COVID-19 vaccines, so that the American public and medical community have trust and confidence in FDA-authorized vaccines. 

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-announces-advisory-committee-meeting-discuss-janssen-biotech-incs

FEB. 26 VRBPAC meeting will be livestreamed on YouTube, Facebook and Twitter channels and webcast the FDA website

Stayed tuned for Federal Register Notice for comment submission.

COVID-19: FDA Authorization of ModernaTX,Inc. Vaccine December 18, 2020

#COVID-19, #Moderna, #modernavaccine

FDA Emergency Use Authorization—Another milestone to combat the COVID-19 pandemic: FDA gave the green light by granting an Emergency Use Authorization (EUA) to ModernaTX, Inc. (Moderna) for its vaccine. Here is the link to the official FDA Press release: https://www.fda.gov/news-events/press-announcements/fda-takes-additional-action-fight-against-covid-19-issuing-emergency-use-authorization-second-covid

Letter of Authorization: https://www.fda.gov/media/144636/download

Why Emergency Use? This is because of the declaration under the PREP Act, which back in the winter of 2020, Health and Human Secretary Alex Azar II officially declared the COVID-19 a pandemic. The FDA grant of emergency use is critical because it allows the use of the unapproved yet authorized vaccine to travel in interstate commerce in essence as an unapproved drug.

Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19 Health and Human Secretary Azar declared a public health emergency pursuant to section 319 of the PHS Act,  for the entire United States to aid in the nation’s health care community response to the COVID-19 outbreak. Azar issued a Declaration pursuant to section 319F-3 of the Public Health Service Act (codified above) to provide liability immunity for activities related to medical countermeasures against COVID-19. See 85 FR 15198 (March 17, 2020) retroactive and renewed effective date Oct. 23, 2020. (U.S.Department of Health and Human Services, Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3. February 4, 2020).

This is the second vaccine (Pfizer BioNTech the first) authorized for the prevention of COVID-19, which is a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older.

Vaccine Adverse Event Reporting System (VAERS) for Moderna COVID-19 Vaccine: According to FDA Moderna is required to report serious adverse events, cases of Multisystem Inflammatory Syndrome (MIS), and cases of COVID-19 that result in hospitalization or death.

https://vaers.hhs.gov

COVID-19 VACCINE RESISTANCE

Does public safety justify mandatory vaccination?

Over 100 years ago, in the early 1900s the United States Supreme Court was faced with the issue of “police power” or the power of state government to protect public health and the Constitution’s protection of personal liberty. In the United States Supreme Court case of Jacobson v Massachusetts 197 US 11 (1905), the Supreme Court upheld the Cambridge Massachusetts Board of Health authority to require vaccination of healthy adults against smallpox due to the epidemic which could compromise the community. The plaintiff, Henning Jacobson, had refused the vaccination and was fined $5.00.

Unlike today, where chronic diseases account for most deaths, at that time, infectious disease was the leading cause of death and states administered public health initiatives. The FDA did not even exist at that time. Yet today, globalization, has essentially required immunizations from infectious diseases. COVID-19 is an example of a pandemic perhaps reminiscent of earlier time periods in history.