Full FDA Approval Would Combat Doubt About Covid Vaccines

We answer your questions about covid-19 24:54

(CNN) – As a condition of the emergency use authorizations issued for the Pfizer / BioNTech and Moderna coronavirus vaccines, those companies are expected to work towards seeking full approval from the US Food and Drug Administration. (FDA), and some health officials hope that will happen soon.These vaccines have been in use since mid-December under emergency use authorizations, known as USA. During the pandemic, real-world data has shown that vaccines are effective against the coronavirus that causes covid-19.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told CNN’s Jim Sciutto on Wednesday that he hopes that covid-19 vaccines will receive full FDA approval “very soon” and that the FDA will work. “As quickly as possible” “on approval requests for coronavirus vaccines as they arrive.

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Going from licensed to approved would allow manufacturers to directly market and distribute their vaccines. It could also have an impact on vaccination mandates, and perhaps sway skeptics who hesitate to get vaccinated now.

The road to FDA approval

Currently, the three COVID-19 vaccines distributed in the United States – made by Pfizer / BioNTech, Moderna and Johnson & Johnson – are licensed but not approved.

Due to the severity of the pandemic, vaccine manufacturers originally requested an EUA because the authorization process takes less time than would be required for full approval. The emergency use authorization is what the name suggests: a medical product, such as a vaccine, that gets special clearance from the FDA for use during an emergency.

When the health emergency is over, “then any US issued based on that declaration will cease to be in effect,” according to the FDA. Therefore, vaccine manufacturers will need to submit a separate application for vaccines to be fully licensed.

CNN has contacted Pfizer / BioNTech, Moderna and Johnson & Johnson, the latest covid-19 vaccine to be licensed, about their plans to request full approval for their vaccines. Neither company provided a timeline.

The typical approval process for vaccine developers requires the completion of Phase 1, 2, and 3 human laboratory research, preclinical testing, and clinical trials. That has already been done with these coronavirus vaccines.

The FDA also requires vaccine manufacturers to submit data to support their manufacturing processes, facilities, product characterization, and demonstration that the vaccine can be produced reliably and consistently.

Once all of that is complete, both clinical trials and manufacturing details, companies can submit a Biologics License Application, or BLA, to the FDA.

“By submitting a BLA to the FDA, a company requests permission to distribute and market a vaccine for use in the United States,” according to the FDA website.

“The FDA evaluates the data to determine if the safety and efficacy of the vaccine have been demonstrated and if the manufacturing and installation information assures the quality and consistency of the product. After its evaluation, the FDA decides whether to approve (also known as license) the vaccine for use in the United States. “

Applications designated as “priority review” mean that FDA’s goal is to take action on an application within six months. A “standard review” could take longer.

“When you’re getting formal approval, you have to have a certain amount of time just predominantly looking at safety, and obviously safety looks very, very good in more than 140 million people who have been vaccinated with at least one dose,” he said. Fauci on CNN on Wednesday.

After all, as the spread of the virus slows, the nation may no longer be in an emergency situation and vaccines will need a different kind of green light under the FDA.

The agency is “the gold standard of a regulatory and security organization around the world,” said Fauci, President Biden’s chief medical adviser. “I hope they do it quickly.”

‘It will help show skeptics that licensed covid vaccines are safe’

One concern about licensed but unapproved vaccines is vaccinated against vaccines.

If history indicates anything, skepticism, if not outright mistrust, of an unapproved vaccine is nothing new.

A study published in 2009, months after the US declared a public health emergency due to H1N1 flu and the World Health Organization declared it a pandemic, researchers explored the public’s willingness to use a drug or vaccine with an EUA – not a full FDA approval – surveying a representative sample of more than 1,500 American adults.

The researchers, from the University of Pittsburgh and the University of Georgia, found that about 77% of respondents would be moderately, very, or extremely concerned if they were offered an unapproved vaccine; 63% said they would not wear it.

But the study also found that there were a few other key factors that would convince respondents that a vaccine licensed under an EUA was safe to use.

If the vaccine were given by a public health professional, 55% of those surveyed said they would get it.

If it came with a fact sheet, just over 57% of those surveyed said they would receive it.

If your own healthcare provider gave the vaccine, that number skyrocketed to 68%.

Dr. Jerome Adams, chief health officer during the Trump administration, wrote in an opinion piece published in The Washington Post on Tuesday that the approval will help show skeptics that licensed coronavirus vaccines are safe.

“We should also seek full approval from the Food and Drug Administration and expand covid vaccines to young people,” Adams wrote in part.

“People who were vaccinated early were generally at high risk and were willing to receive a vaccine licensed for emergency use. But many people who are at lower risk, understandably, ask whether the benefits justify taking a drug that has not received the full and traditional seal of approval from the FDA, “he wrote.

“As vaccine manufacturers complete more studies, which will eventually lead to greater eligibility among minors, it will help show skeptics that licensed covid vaccines are safe.”

Plans to require the vaccine

Some organizations say they hope to require the vaccine, but have chosen not to do so while it is licensed and it is not yet fully approved.

“People, when they hear that it is still an emergency use, they still have a little bit of concern about how far it can go,” Fauci said on CNN Wednesday.

The University of California and California State University systems announced last week that their universities intend to require faculty, staff, and students to be vaccinated against the coronavirus, but the requirement would take effect only once the vaccine has received full FDA approval. The proposed policy would begin this fall.

The California State University noted in its announcement that “this requirement will go into effect at the beginning of the fall term of 2021, or with the full approval of the vaccine by the FDA, whichever occurs later.”

CNN’s Dr. Sanjay Gupta, Andrea Kane, and Naomi Thomas contributed to this report.

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