coronavirus vaccine

Pfizer, Moderna Vaccines Head for FDA Review

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On Monday, Moderna announced it will file for emergency use authorization for its COVID-19 vaccine, setting the stage for two possible vaccines that could be available by the end of the year.

“The first company and vaccine that’s ahead of the pack is the Pfizer vaccine and the FDA will sit on it December 10,” said Dr. Onyema Ogbuagu, said an associate professor of medicine at Yale School of Medicine, who also works in infection prevention at Yale New Haven Hospital. “The hope is that if there is approval it will be mid-December.”

Ogbuagu has worked on the Pfizer clinical trial at Yale New Haven Hospital. He said Pfizer will be reviewed by the FDA on Dec. 10, with Moderna’s review a week later on Dec. 17.

It’s encouraging that two vaccines could be available by the end of the year, but Ogbuagu said we need to keep one thing in mind.

“I think we need to remind ourselves these companies are not just producing vaccines for the US, but they’re also trying to meet global demand,” he said.

“I can tell you we gotta move pretty fast. We are going to get vaccines,” said Gov. Ned Lamont during Monday’s COVID-19 news briefing. “We are going to get it before the end of the year, middle of December, Dec. 14 is the date they’re hoping for Pfizer.”

Lamont went on to discuss the state’s plan for getting the vaccines out once they are approved.

“We’ve worked very hard with CVS, Walgreens to make sure they have the distribution in place. [We’re] focused on nursing homes and we can also get that out to the hospitals.”

The CDC’s Advisory Committee on Immunization Practices will meet Tuesday to discuss national guidance for states on a distribution plan.

With two vaccines on the horizon and possibly more on the way as other trials conclude, it will still take some time before there’s widespread public availability. But for those who will receive it first once it’s approved, the process for getting it out could move quickly.

“We could be expecting a fairly wide distribution and a quick distribution once it gets to that stage,” said Karl Minges MPH PhD, head of the MPH program at the University of New Haven.

Once approved, Minges said he expects the vaccines to be available to the public by mid-2021, and the variations could be helpful in the fight against COVID.

“What’s encouraging about that is that each vaccine may work a little differently, have different ways that it can be distributed, in terms of the vaccine must be kept in cold conditions versus not,” said Minges.

That will help guide how people will be able to get the vaccines. Minges said Pfizer’s vaccine may be used for hospital workers since there is an infrastructure to keep it well below zero, while other vaccines don’t require extremely cold temperatures may be more suited for the public.

He said insurance coverage could also play a part in which vaccines people get and when.

Those are all details that will have to be finalized. Minges added an important part of the plan should include talking to people about the importance of vaccinations. He says 60% of people say they’ll get a vaccine.

“What’s encouraging about that is that it’s actually higher than flu vaccinations, or the perceived number of people who get the flu vaccination per year,” said Minges. “The disadvantage is that we still have to convince those 40% of people that whatever the FDA approves is safe and efficacious.”

He said outreach should also focus on demographics.

“It’s so important to reach out to people that perhaps live in housing that is multigenerational or that live in apartment buildings, places where it’s more easy to transmit the virus because you’re in close contact with others.”

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