- Coronavirus vaccines are moving toward deployment, with the FDA set to review the first two later this month.
- Two drugmakers — Pfizer-BioNTech and Moderna — have submitted applications to the FDA for emergency use authorization (EUA) for their vaccines.
- Millions of people may be able to get vaccinated against COVID-19 this month.
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As the COVID-19 pandemic drags on, and the United States sees an alarming winter surge in cases, coronavirus vaccines offer us hope of regaining some semblance of a normal life next year.
In recent weeks, a flurry of developments has brought these vaccines closer to being deployed, with the Food and Drug Administration (FDA) set to review applications for two vaccines later this month.
Here’s a breakdown of what to expect over the coming weeks and which groups will likely be vaccinated first.
Two drugmakers — Pfizer-BioNTech and Moderna — have submitted applications for emergency use authorization (EUA) for their vaccines to the FDA.
These applications are based on final results from the companies’ phase 3 clinical trials.
The FDA’s independent
Angela K. Shen, ScD, MPH, a visiting research scientist at the Vaccine Education Center at Children’s Hospital of Philadelphia, said based on that review, the committee will make a recommendation to the FDA about whether the vaccines should be approved.
“The FDA still has to decide whether or not they’re going to give [the vaccine] a thumbs up or thumbs down,” she said.
These initial applications are for emergency use. If approved, the vaccine would be available to high-risk groups such as healthcare and other essential workers.
The FDA would need to review an application for full licensure at a later date before the vaccine could be distributed to other groups.
Operation Warp Speed advisor Moncef Slaoui, PhD, told CNBC that vaccines could be available at immunization sites within 24 hours after an EUA is approved.
The big question is how long it will take the FDA to make its final decision after the advisory committee meetings.
On Monday, Vice President Mike Pence said during a conference call with the White House Coronavirus Task Force that vaccine distribution could begin as early as the week of December 14 — four days after the public meeting for the Pfizer-BioNTech application.
Vaccine makers started manufacturing doses even while the phase 3 trials were ongoing, in anticipation of a fast rollout.
Moderna, which was part of Operation Warp Speed, expects to have around 20 million doses of its vaccine available in the United States by the end of the year, with up to 1 billion globally in 2021.
Pfizer expects to have 50 million doses of its vaccine available globally by the end of this year, with an additional 1.3 billion doses in 2021.
This group was not part of Warp Speed, but they plan to distribute 6.4 million doses to U.S. states by mid-December, reports NPR.
These are two-dose vaccines, so if both are approved, there would be enough available this year to vaccinate around 13 million Americans.
A vaccine advisory committee for the Centers for Disease Control and Prevention (CDC) estimates it may be higher — 40 million doses by the end of December, or enough to vaccinate 20 million people.
The committee also anticipates that an additional 5 million to 10 million doses will be available each week after that as manufacturers ramp up production.
Initial doses of Pfizer’s vaccine will be shipped to states based on population, according to NPR. States will then decide how to distribute the vaccine.
Initial doses will be given to people most at risk from the coronavirus, which is not a small number.
This adds up to 264 million at-risk people, much more than the initial available doses.
The CDC’s vaccine advisory committee recommended on Tuesday that initial doses be given to healthcare workers and long-term care facility residents.
While states will take cues from the CDC’s guidelines, they may also develop their own priority lists and vaccination plans.
“States will implement the [federal] guidelines to the best of their ability, keeping in mind what’s best for their population,” said Shen. “For example, some states are more rural than others — Alaska doesn’t look the same as New York. So how each state distributes the vaccine will look different, because each state is different.”
Technical factors will also play a part in how states distribute the vaccines, especially storage of the vaccines.
Pfizer’s vaccine can be stored for up to 6 months in an ultracold freezer, which not every hospital has access to. It can also be stored in a special container with dry ice for up to 15 days. Once thawed, though, the vaccine needs to be used within 5 days.
Moderna’s vaccine is less temperature sensitive — it can be stored at standard refrigerator temperatures for up to 30 days.
According to initial plans, some states plan to distribute initial doses to hospitals, public health departments, or other organizations that can quickly vaccinate large numbers of people without the need for specialized freezers or other cold storage.
As more doses become available, states will work through the priority groups outlined by the CDC and their own assessment.
The CDC’s committee will meet again later to discuss the prioritization of these other groups.
However, earlier discussions by the committee suggest that police, firefighters, food and agriculture workers, and other essential workers would be next in line. This would be followed by adults over age 65 and adults with high-risk medical conditions.
UCLA public health and urban planning experts also developed a model that can be used to help states target groups most at risk.
This model goes beyond looking at just age and preexisting medical conditions to also consider barriers to accessing healthcare, characteristics of a person’s environment that affects their risk of infection, and socioeconomic challenges.
“You have to start thinking about not just standard demographics, but also the context in which things occur that could result in higher infection rates,” said Vickie Mays, PhD, a professor of health policy and management in the UCLA Fielding School of Public Health.
“In our model, we started thinking about other variables that increase the likelihood that, if the virus is present in a neighborhood, that a person would get infected,” she added.
For example, infections are more likely to spread among people who live in crowded housing or multifamily housing than those who live in large houses with good ventilation and few people living there.
Because there are so many high-risk people in the United States, those with the lowest risk — such as healthy young adults — may not be vaccinated until the “second quarter, third quarter of 2021,” Adm. Brett Giroir, MD, the White House’s coronavirus testing czar, told CNBC on Sunday.
Children may have to wait until late in 2021 or even longer, because clinical trial data is not available for this group.
Vaccine trials only include children as young as 12 years, and these trials didn’t start until October. Younger children and pregnant people have not yet been included in any trials.
Shen said that given this timeline, we will need to remain diligent about protective measures like wearing masks and physical distancing.
“While things should get better when enough people are vaccinated, we can’t let our guard down,” she said. “Especially since we still don’t know the duration of the protection offered by these vaccines.”