Pfizer COVID-19 Vaccine Receives EAU Authorization Recommendation

 

TAG Answers Vaccine Questions

On Thursday, December 10, the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended that the FDA issue an Emergency Use Authorization (EAU) for the Pfizer COVID-19 vaccine. The proposed use under the EUA is “for active immunization for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older.” The proposed dosing regimen is 2 doses, 30 µg each, administered 21 days apart.

 

As stated in the meeting Briefing Document, “FDA has reviewed the CMC data submitted to date for this vaccine and has determined that the CMC information is consistent with the recommendations set forth in FDA’s Guidance on Emergency Use Authorization for Vaccines to Prevent COVID-19. As such, FDA has determined that the Sponsor has provided adequate information to ensure the vaccine’s quality and consistency for authorization of the product under an EUA.”

 

According to a New York Times article, FDA is expected to grant the EUA on Saturday, though the sources who are familiar with the agency’s planning “cautioned that last-minute legal or bureaucratic requirements could push the announcement to Sunday or later.”

 

Once the final, formal approval is issued, it will likely be up to the states to determine distribution. (See Q3 below.)

 

Also announced today was a setback in a vaccine under development by GlaxoSmithKline (GSK) and Sanofi after trials showed that it failed to produce a strong immune response in people over 50.  The vaccine is not expected to be available for distribution until late 2021.  This vaccine is one of six that were selected by Operation Warp Speed, the federal government’s effort to quickly bring a vaccine to market. The companies negotiated a $2.1 billion agreement with the United States to provide 100 million doses.  This vaccine is based on viral proteins produced with engineered viruses that grow inside insect cells. GSK supplemented these proteins with adjuvants that stimulate the immune system.

 

 

Vaccine Q&A

Since the end of February, TAG has kept a close eye on everything COVID to keep our clients and newsletter readers informed. In the same way, we are now staying current on vaccines – from their development to availability and effects, to ensure we bring you the latest science and solutions.

To assist in this initiative, we will be including a weekly Q&A in the COVID-19 newsletter and an online FAQ page, which we will be regularly updating to answer your questions and keep you informed.

 

Q1. What is required for FDA’s issuance of an EUA?

A. Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Emergency Use Authorization (EUA) gives the FDA Commissioner authority to allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by (Chemical, Biological, Radiological or Nuclear (CBRN) threat agents when there are no adequate, approved, and available alternatives. Thus FDA may issue an EAU if:

• CBRN agent referred to in the March 27, 2020 EUA declaration by the Secretary of HHS (SARS-CoV-2) can cause a serious or life-threatening disease or condition.

• Based on the totality of scientific evidence available, including data from adequate and well-controlled trials, if available, it is reasonable to believe that the product may be effective to prevent, diagnose, or treat such serious or life-threatening disease or condition that can be caused by SARS-CoV-2, or to mitigate a serious or life-threatening disease or condition caused by an FDA-regulated product used to diagnose, treat, or prevent a disease or condition caused by SARS-CoV-2.

• The known and potential benefits of the product, when used to diagnose, prevent, or treat the identified serious or life-threatening disease or condition, outweigh the known and potential risks of the product.

• There is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating the disease or condition. If these criteria are met, under an EUA, FDA can allow unapproved medical products (or unapproved uses of approved medical products) to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by threat agents.

 

Q2. I’ve read that the cold-chain temperature requirements of vaccines that are closest to roll-out limit that amount of time that they are “fresh” – and that two doses will be required. Can you provide more information on this?

A. There are three vaccines that have undergone late-stage clinical trials [link to Vaccines 101] and are closest to or have received FDA authorization. Following are the dosage and temperature requirements for these:

• Pfizer. The two-dose vaccine to be receive d about 21 days apart received a recommendation for FDA EUA approval from its vaccine advisory committee on December 10. The biggest challenge will be storage and distribution: Due to the low-temperature storage conditions (-94), Pfizer has developed temperature-controlled thermal shippers utilizing dry ice to maintain recommended temperature conditions of -70°C±10°C for up to 10 days. If the vaccine is stored in refrigerated (2 – 8°C) conditions, it can be stored for up 5 days. Once thawed and stored under 2 - 8°C conditions, the vials cannot be re-frozen. Read Pfizer’s plan. Once in the refrigerator, the vaccine must be used within 5 days.

• Moderna. Two-dose vaccine – people will need to receive two doses about 28 days apart. The biggest challenge will be storage and distribution: Vaccine can be shipped at -20C (-4F) and stored for up to 6 months at that temperature. However, once thawed and in the refrigerator (2 – 8°C), the vaccine can be stored for up to 30 days.

• AstraZeneca & Oxford University. Two-dose vaccine – people will need to receive two doses. Storage: The AstraZeneca vaccine can be transported and stored at refrigerator temperatures (2 – 8° C), which makes this vaccine much more accessible than the others.

For more information, visit TAG’s overview and Vaccine 101 paper (pdf).

 

Q3. Since we are in a critical infrastructure business, I’ve heard talk that our access to the vaccine is right around the corner. What do you see as realistic timing /expectations – recognizing that this is a fluid situation.

A. This is a fluid situation, and it is one in which the states will be making the priority determinations. But the expectation is that most states are likely to follow the recommendations that were made by the CDC Advisory Committee on Immunization Practices (ACIP) in a November meeting -- a phased-in process, prioritizing healthcare workers and long-term care facility residents. The first phase of the ACIP proposal then includes vaccination essential workers followed by adults with high-risk medical conditions and those over 65. (See graphic below)

 

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