FDA Authorizes use of Moderna COVID-19 Vaccine

December 18, 2020 – As expected, the FDA has granted Moderna emergency use authorization for its COVID-19 vaccine, doubling the number of vaccine doses expected to be available in the coming days for nationwide distribution .

There is one final step: The CDC’s Advisory Committee on Immunization Practices will need to recommend its use, as it did 2 days after the Pfizer vaccine received its EUA on December 10.

The EUA for the Moderna vaccine is “a major step in the attempt to contain this pandemic,” Hana Mohammed El Sahly, MD, told Medscape Medical News.

The extension of the distribution of the two vaccine products will come next.

“Even in less emerging conditions, it can sometimes be difficult to make sure that people who need to be vaccinated can be difficult. I hope that the media attention on this will make more people aware that there are vaccines that could help them ”.

said El Sahly, chairman of the FDA Advisory Committee on Vaccines and Related Biologics (VRBPAC).

The emergency authorization for the Moderna vaccine follows a review by the independent committee on Thursday, which voted 20 to 1 with one abstention to recommend the authorization.

The emergency approval of a second COVID-19 vaccine “is great – we need every tool possible to fight this pandemic. Early data from Moderna looks good, and I agree with the FDA to say that an EUA is indicated, “Stephen Schrantz, MD, infectious disease specialist and assistant professor of medicine at UChicago Medicine, told Medscape.

“It behooves all of us healthcare professionals to show ourselves as supporting this vaccine and helping people get it,” said Schrantz. “We want to make sure that the people who are on the fence understand that this is a safe vaccine that has been approved appropriately by the FDA and through Phase III clinical trials.

“I know the vital role physicians play as influencer vaccines,” American Medical Association president Susan Bailey, MD said in a Dec. 14 webinar for reporters. “We have to keep doing what doctors have always done. Examine the evidence and trust the science. Lives are at stake. ”

Increase immunization of health care providers

“I am very happy to see the positive evaluation of the Moderna vaccine by the FDA. We were waiting for another vaccine that we could use for healthcare workers and staff – and now we have it”, Aneesh Mehta, MD, from Emory University School of Medicine in Atlanta, told Medscape.

“We were hoping for a vaccine with 70% or 80% efficiency to see, and now to see two vaccines with more than 90% efficiency is remarkable,” he added.

The efficacy levels associated with the Pfizer and Moderna messenger RNA vaccines “certainly exceeded expectations – that’s not what we built the studies on. It was surprising in a good way,” El said. Sahly, also a partner. professor of molecular virology and microbiology and researcher in the vaccine and treatment evaluation unit at Baylor College of Medicine in Houston.

There are still unanswered questions

Schrantz also said the high efficacy rate was positive. “That being said, what we do know about this vaccine is that it is very effective in preventing disease. We do not yet know whether or not these vaccines prevent infection and transmissibility.”

Bailey said: “The jury is still out on whether you can still transmit the virus after receiving the vaccine. Hopefully not, but we don’t really know for sure.”

“It’s risky to think that once you get the bullet in the arm everything will go back to normal. It doesn’t,” added Bailey..

Another unknown is the duration of protection after vaccination. The Pfizer and Moderna products “have similar constructions, appear to have a reasonable safety profile, and excellent short-term efficacy,” said El Sahly. She cautioned, however, that long-term effectiveness has yet to be determined.

Whether rare adverse events will emerge is another question. Answers could come with the time of the phase III trials in progress, as well as the follow-up of the vaccinated.

Our work is not finished after the publication of an EUA, ”said FDA Commissioner Stephen Hahn, MD, during a JAMA webinar on December 14. The FDA is closely monitoring adverse event rates above the normal background incidence. “We’re going to be transparent about this if we see something that isn’t at the baseline. “

Benefits beyond the numbers?

“The major advantage of having two vaccines is the volume,” Mehta said. An added benefit of more products is the ability to offer an option when a specific vaccine is not recommended for specific individuals. “We could give someone a different vaccine … similar to what we do with the flu shot.”

“The more the merrier in terms of having more vaccine products,” Schrantz said. Despite differences in shipping, storage, minimum age requirements, and dosing intervals, the Pfizer and Moderna vaccines are very similar, he said. “In reality, the only difference between these two vaccines is the proprietary lipid nanoparticle – the delivery vehicle if you will.

The two vaccines “appear to be very similar in their ability to protect against disease, to protect [people in] diverse racial and ethnic backgrounds, and in their ability to protect themselves against serious illness, ”said Paul Offit, MD, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a member of the FDA advisory committee.

Regarding the vaccines in development, “We don’t know but we might start to see a difference with the Johnson & Johnson vaccine or the Janssen vaccine, which are single dose. They may confer some benefit, but we are waiting for the safety and efficacy data, ”said Schrantz.

As a two-dose vaccine, the AstraZeneca product dose does not offer an advantage over dosing strategy, “but it is easier to transport than mRNA vaccines,” he said. Some concerns about the initial AstraZeneca vaccine data will likely need to be addressed before the company requests an EUA, Schrantz added.

“This is an important question,” El Sahly said. Ongoing studies should provide more data from participants of all ages and ethnicities that “will allow us to determine if there is a difference between these two vaccines.”

She added that the Pfizer and Moderna vaccines appear comparable based on early data. “We’ll see if that holds up for the long term.”

Future prospects

Now that the FDA has approved the emergency use of two COVID-19 vaccines, “we need every state to quickly implement their plans to get the vaccines into the hands of the providers who need to administer the vaccines,” said Mehta. “We are witnessing a very effective deployment in several regions of the country. And we hope that will continue as we receive more vaccines from manufacturers in the coming months.

“Less than a year after identifying the sequence of this virus, we have two major vaccine clinical trials showing efficacy,” said Offit. “It was an incredible technological achievement, but now comes the hardest part. Mass-producing this vaccine, spreading it, making sure that everyone who benefits most benefits from it, will be really, really difficult.”

“But I am optimistic,” Offit said. “If we can do this by Thanksgiving, we’re going to see a dramatic drop in the number of cases, hospitalizations and deaths, and we can get our lives back.”

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