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Pfizer, Moderna Support COVID Vaccine Booster Before FDA Meet

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The FDA’s Vaccines and Related Biological Products Advisory Committee is scheduled to meet tomorrow to discuss the effectiveness and necessity of the booster dose of Pfizer PFE / BioNTech’s BNTX COVID-19 vaccine, Comirnaty. Pfizer has submitted a supplemental biologics license application seeking approval for booster dose of Comirnaty last month based on data from a multi-phase study. The vaccine is the only FDA-approved COVID-19 vaccine for adults as well as individuals aged more than 16 years.

All other available vaccines — namely Moderna’s MRNA mRNA-1273 and J&J’s JNJ COVID-19 vaccine — are authorized for emergency use in adults in the United States.

Is a Booster Dose Necessary?

Reportedly, there seems to be a tussle among health officials determining the necessity of a booster dose currently. However, rising cases of COVID-19 infections due to the prevalence of the Delta variant are putting pressure on officials to bring a viable option to increase protection against the variant to contain spiraling infections cases in the United States and other countries. The FDA has already approved the booster doses of Comirnaty and mRNA-1273 for immunocompromised adults last month. Last month, the U.S. government had decided to start providing booster doses to the country’s citizens beginning Sep 20, if necessary approval is given by the FDA.

The vaccination of adults started in the United States late in 2020 following emergency use authorization to Comirnaty and mRNA-1273, the two leading COVID-19 vaccines. Tens of millions of American citizens have already received one or two doses of the vaccines to protect themselves against the COVID-19 infection.

Currently, Pfizer and Moderna are trying to get an authorization/approval for a booster dose of their respective COVID-19 vaccines. The companies have provided clinical data to support the efficacy of a booster dose to the FDA. These data also raise warning signs about fading immunity against breakthrough COVID-19 infections after six to eight months of the initial vaccine regimen. Data from several real-world studies also showed that the immunity against COVID-19 vaccines has decreased over time. Booster doses have demonstrated a significant increase in immunity levels compared to the levels achieved following the initial regimen in clinical studies.

We note that several millions of U.S. citizens have received the initial two-dose regimes of the vaccines at least six months ago. With signs of fading immunity in individuals amid the rising infection cases, the FDA advisory committee meeting tomorrow seems to be a crucial one for the future of booster doses in the near term. However, it is expected that booster doses will be eventually needed.

Booster Data from Pfizer

Data from Pfizer's COVID-19 vaccine booster study showed that one month after the booster dose, the level of SARS-CoV-2 neutralizing titers (a measure of the immunity level) against the wild-type strain were 3.3-fold higher than the levels achieved following one month of the initial two-dose regimen. Per a Bloomberg video, Pfizer stated that immunity following the initial regimen faded over time but the rate of decline remains uncertain. However, the immunity against severe cases or hospitalization remains strong per the FDA advisory committee meeting’s briefing document.

Booster Data from Moderna

Earlier this week, Moderna provided clinical data, supporting the effectiveness of a booster dose of mRNA-1273. The data suggested that the risk of breakthrough infection was higher in individuals who received their first vaccine dose 13 months ago compared to the ones receiving the dose eight months ago, implying a decline in immunity. Per an interim estimate by the CDC, the effectiveness of mRNA-1273 remained 92% for COVID-19 infections and 95% against severe cases following approximately three months of vaccination.

Although Pfizer and Moderna are the only two companies vying for a booster currently, there are several other pharma/biotech companies that may join the race sooner or later. J&J reported positive interim data from two phase I/IIa studies evaluating the booster dose of its COVID-19 vaccine last month. Other companies that may join the vaccine race in the United States in a few months include AstraZeneca AZN and Novavax NVAX among others. AstraZeneca’s COVID-19 vaccine has been authorized for emergency use in many parts of the world but it is not authorized in the United States yet.

Booster Dose May Drive Prospects

Please note that the coronavirus vaccine has significantly boosted the top line of Pfizer, BioNTech, and Moderna in the first half of 2021. BioNTech and Moderna have also enjoyed a significant increase in their share prices since 2019-end driven by their success with their COVID-19 vaccines. Potential support for the booster dose of Comirnaty in tomorrow’s advisory meeting, and subsequent potential green signal from the FDA, will be further beneficial for the share prices of all the three companies. Although the meeting is for Comirnaty, a positive outcome will also boost the prospects of an authorization for the booster dose of mRNA-1273 too.

Among the companies with authorized/approved COVID-19 vaccines in the United States, Moderna carries a Zacks Rank #2 (Buy) while Pfizer, BioNTech and J&J carry a Zacks Rank of 3 (Hold). You can see the complete list of today’s Zacks #1 Rank stocks here.

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