When will we have a COVID-19 vaccine?

We have several promising candidates — so why aren’t regulators approving them?

For months, researchers across the globe have been racing to develop a safe, effective COVID-19 vaccine — and several have arguably crossed the finish line.

In November, so far, three developers (Pfizer, Moderna, and the University of Oxford) have announced vaccine efficacy of 90% or higher in large phase 3 trials, far exceeding many health experts’ hopes for a vaccine.

In general, these COVID-19 vaccines appear safe and produce few severe side effects (although they may be unpleasant for some).

Yet despite this coronavirus vaccine progress, the vast majority of the world’s population still doesn’t have access to a vaccine. So: when will we have a COVID-19 vaccine — and what’s taking so long?

Yes, Some Vaccines Are Approved But…

So far, the only places that have approved COVID-19 vaccines for use outside of trials are Russia and China — and both nations granted their limited approvals without waiting for the results of phase 3 trials.

Health experts across the globe labeled those decisions everything from a “terrible idea” to “beyond stupid,” as phase 3 trials are the gold standard for testing both a vaccine’s safety and its efficacy.

But now that phase 3 results are in, how long will it be before one of these candidates gets approved?

When Will We Have a COVID-19 Vaccine?

Every nation has its own health agencies tasked with deciding whether a vaccine is ready for distribution (the FDA in the U.S., the MHRA in the U.K., etc.). That means the point in time when you will have to COVID-19 vaccine depends on where you live, as well as how many vaccines have been produced for your country.

In the U.S., vaccine developers are allowed to apply for an emergency use authorization (EUA) from the FDA once their phase 3 trial meets specific criteria — it must include a minimum number of participants, for example, and a minimum length of time since vaccination to record side effects.

Pfizer has met that criteria and submitted its EUA application on November 20, while Moderna said on November 16 that it planned to submit its application “in the coming weeks.”

Oxford and its partner, AstraZeneca, said on November 23 that they were “immediately preparing” their applications for the FDA and other regulatory agencies, including the WHO — that approval would allow the group to distribute its vaccine to low-income countries.

What’s Taking So Long?

Despite all the encouraging coronavirus vaccine progress announced in November, no one in the U.S. is likely to receive a COVID-19 vaccine before mid-December — and the reason for the wait is hard to explain and even harder to understand.

There’s a lot of red tape keeping things from moving as fast as they could.

Before the FDA makes a decision about Pfizer’s COVID-19 vaccine, it plans to have a group known as the Vaccines and Related Biological Products Advisory Committee (VRBPAC) review the application.

The members of the group will then vote on whether they think the FDA should approve the vaccine, and the FDA will take that recommendation into consideration when making its own decision.

The FDA is required to publicly announce VRBPAC meetings at least 15 days in advance, and despite the urgency of the situation, it not only didn’t shorten that timeframe, but actually scheduled the VRBPAC meeting for 20 days out: December 10.

If the committee votes that day, there’s a chance the FDA might decide to issue an EUA the next (December 11) — but there’s also a chance might take a week or even two.

This whole process needs to be repeated for every vaccine.

If the FDA does issue an EUA, distribution of the vaccine to clinics and doctors’ offices could begin within 24 hours, but healthcare workers can’t start administering the vaccine until another group signs off: the CDC’s Advisory Committee on Immunization Practices (ACIP).

That group will decide who should get the vaccine first, and, best case scenario, it could vote as soon as December 12. Once it makes its decision, immunizations can begin.

This whole process will need to be repeated for every vaccine that submits its EUA after Pfizer.

Long story short: there’s a lot of red tape keeping things from moving as fast as they could in the U.S. (or as fast as they are moving in other countries).

When Will You Be Able to Get a Vaccine?

Unless the FDA moves up its committee meeting (and there’s no indication that’s happening), the earliest anyone in the U.S. is likely to get a vaccine would be December — but will you be one of the first in line?

There won’t be enough doses to vaccinate every person in the U.S. when the FDA issues its first approval for a COVID-19 vaccine — Moderna and Pfizer combined will only have enough to vaccinate about 20 million people in the U.S. in 2020 — so we need to decide in advance who should get it first.

As mentioned, the ACIP will have the final say in this, but almost everyone agrees that healthcare and other frontline workers should be the first to receive a vaccine.

Your job and your COVID-19 risk could determine your place in line for a vaccine.

Who should get it next isn’t as cut and dry, but a number of researchers are already weighing the variables in search of the ideal roll out.

According to one group in Washington state, vaccination order should depend on a combination of a vaccine’s efficacy and the number of doses available.

For example, if the FDA approves a vaccine that’s 90% effective, but we can only have enough doses for 10% of the population, all of those doses should go to people over the age of 65 to minimize deaths.

In contrast, if a vaccine is only 50% effective, but there are enough doses to vaccinate half of all Americans, it would be better to give the first vaccines to healthy people under the age of 50, the researchers concluded, to slow or stop the spread of the virus.

That means your place in line may depend on some combination of your job, your COVID-19 risk, and the specific vaccine — whenever the FDA finally gets around to approving one.

We’d love to hear from you! If you have a comment about this article or if you have a tip for a future Freethink story, please email us at [email protected].

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