The Pfizer/BioNTech vaccine crossed the finish line first, likely to be followed by Moderna, but other conte

Author : torunlota

Publish Date : 2021-01-09 14:58:39

The Pfizer/BioNTech vaccine crossed the finish line first, likely to be followed by Moderna, but other conte

Timeline
Q: What vaccines have been approved by the FDA?

Late on Dec. 11, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) that allows use of an mRNA vaccine made by Pfizer and BioNTech. A estimated 2.9 million vaccines will be shipped over the subsequent week. The decision came the day after the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) reviewed data on the vaccine’s safety and effectiveness and recommended the FDA issue an EUA.

A week later on Dec. 18, the FDA issued an EUA for the other mRNA vaccine made by Moderna, who submitted their EUA request to the FDA November 30. Both these mRNA vaccines met the minimum requirement by the FDA of at least two months of data after vaccination and efficacy of at least 50%.

After the FDA approves a vaccine, whether through the traditional method or under an EUA, the next step is review by the Advisory Committee on Immunization Practices (ACIP) at the Centers for Disease Control and Prevention. It’s likely ACIP will issue its recommendations on who should get the vaccines very soon. An estimated 40 million vaccines — enough for 20 million people to get two doses each — are already set aside for distribution.

Q: What other vaccines are likely to head to the FDA soon?

The Pfizer/BioNTech vaccine crossed the finish line first, likely to be followed by Moderna, but other contenders are close on their heels. Five of the 12 vaccine candidates in phase 3 trials — the final phase before the company can file for FDA approval — are in the U.S. AstraZeneca and the University of Oxford published data from their phase 2/3 trial in The Lancet on November 19 and are currently preparing to submit their vaccine for approval to the FDA and regulatory authorities in other countries. The two vaccines developed by Novavax and Janssen are likely to follow, depending on what their trials show.

“It may be that other vaccines in the pipeline turn out to be better than these front-runners,” Moss said. “These front-runners aren’t the optimal vaccines. We would ideally have a vaccine that doesn’t have the stringent cold chain requirements that the mRNA vaccines require. Ideally, we’d have a vaccine that conferred long-term protective immunity after a single dose rather than two doses. And we also want to make sure we have the optimal vaccine for different subpopulations.”

Even if the FDA greenlights all five of these vaccines, it could also end up approving any of the other eight vaccines currently in phase 1 or 2 trials. After all, there are currently 10 licensed flu vaccines in the U.S.

Q: If the two mRNA vaccines get approved, why would we need so many other vaccines?

Right now, we don’t know how many vaccines we will ultimately end up with, but Omer hopes it will be at least three or four.

“When you deploy a new vaccine, you want to make sure you hedge your bets,” he said. “In case you discover something in post-marketing surveillance, if you have to pull one from the market, you still have others. It’s too important to be a one-vaccine market.”

It’s also particularly important to have different options in a diverse population. “We may learn that certain types of vaccines are better in certain populations,” Moss said.

Q: Does the release of a vaccine mean things will get back to “normal” soon?

Things will eventually get back to normal, but it will take more than a few months, and it will be gradual, explained Moss. “These vaccines are not going to be the silver bullet that brings us back to the pre-pandemic period. We’re still going to need, particularly in the months going forward, to continue to wear masks, socially distance, wash hands frequently, and avoid large gatherings. I think we’ll see over the course of 2021 a more phased return to our normal pre-pandemic life.”

Q: Can I go back to my pre-Covid lifestyle (no masks, going wherever I want, meeting with groups, traveling) once I get the vaccine?

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