Pfizer hits milestone requesting emergency use authorization for COVID-19 vaccine
COLUMBIA, S.C. (WIS) - Pfizer and BioNTech hit a milestone on Friday on the road to a widespread COVID-19 vaccine by submitting their application to the Food and Drug Administration for an emergency use authorization of its experimental COVID-19 vaccine.
The company is the first to request an EUA with Moderna announcing earlier this week they will be requesting authorization in the coming weeks.
Officials have stressed that help is on the way with the vaccine developments this week. With Pfizer requesting emergency use approval on Friday, officials with the South Carolina Department of Health and Environmental Control said we could be talking about a few weeks until rollout begins.
DHEC said they will focus on specific groups such as healthcare workers in the initial rollout, but it’s probably going to be months before anyone can walk into an administration site and get the vaccine.
Millions of vaccines from both Pfizer and Moderna are already packaged, and ready to go. Dr. Jennifer Grier, a University of South Carolina School of Medicine Greenville Immunology professor, said both Pfizer and Moderna have been producing millions of the vaccine ahead of approval. Pfizer officials said they are going to have 50 million doses available this year and 1.3 billion in 2021.
“What’s happening this year that I’ve never seen before is we are actually manufacturing vaccines before they’ve been approved,” Grier said.
All that’s left is for the FDA to give the green light on Pfizer’s Emergency Use Authorization request. However, health officials warn that weeks of waiting still lie ahead.
“That process FDA estimates will take at least two weeks, and if there are any questions of course those questions would need to be addressed and that would delay it further,” Dr. Jane Kelly, DHEC Assistant State Epidemiologist, said. “When we say they are applying for EUA in the next few days, that certainly doesn’t mean it will be available in the next few days.”
Rather, State Epidemiologist Dr. Linda Bell said it could be months for the general population.
“The limitation is the availability of the number of doses, so although we know they are safe and effective vaccines, we won’t have a lot to go around at least initially,” Bell said.
Bell added DHEC has a three-phase distribution plan ready to go for when that day comes.
Phase One, which could be rolled out in a matter of weeks once the vaccine is approved, focuses on reaching the most at-risk populations. This includes healthcare workers, critical infrastructure workers, and possibly nursing home residents. Bell said during this time, they expect a limited supply of vaccine doses.
“Before we get sufficient vaccination in the population as a whole we’re really looking at a matter of months,” Bell said.
Next in the plan is Phase Two. Bell said it could be months before this phase begins and will begin when a large number of vaccines are available. It’s going to include targeted at-risk groups, as well as expanded to include the general population.
Phase Three will begin once there are sufficient doses for the entire population. The focus will be on making sure receiving the vaccine is equitable across the entire state.
The timeline and effectiveness of the vaccines are things both health officials and experts said is encouraging.
“We have seen this level of vaccine efficacy before, but it’s just really shocking that it’s happened so very quickly. It was our first attempt, and it’s for a very novel virus,” Grier said.
Bell said that both the Moderna and Pfizer vaccine will be coming to South Carolina, and residents will be notified which vaccine they are receiving. She said the reason is that both require two doses, with the second dose needing to happen three weeks after the first.
Storage of these vaccines is something DHEC officials are also working on. The Pfizer vaccine needs to be stored in dry ice to be kept at minus 80 degrees Celsius, and the Moderna vaccine needs to be kept at minus 20 degrees Celsius.
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