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FDA Aims to Fully Approve Pfizer-BioNTech Vaccine by Sept

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Pfizer-BioNTech COVID-19 Vaccine comirnaty original vaccine vial | FDA Aims to Fully Approve Pfizer-BioNTech Vaccine by Sept | featured

The US Food and Drug Administration (FDA) is accelerating its timeline to fully approve the Pfizer-BioNTech vaccine for coronavirus. A new surge of infections is presently sweeping the country. Having a vaccine that received full approval instead of emergency use authorization can help convince a lot of unvaccinated Americans to get their shots.  

RELATED: WHO Warns Against Mixing Different COVID-19 Vaccine Brands

Pfizer-BioNTech Vaccine Up For Review

Even US President Joe Biden is hoping for a fully approved vaccine by early fall. In response, the FDA agreed that a fully approved vaccine might give Americans more confidence to trust it. As a result, they are planning to move their timeline up to Labor Day or earlier for full approval. Within the organization, FDA officials are taking an “all hands on deck” approach to complete the processing as soon as they can. 

Getting full approval instead of a EUA can help accelerate the US program of vaccinating Americans from coronavirus. The timing is crucial, as the country is presently dealing with a resurgence that threatens to hold the economy hostage once again. 

Full Approval Means Easier Mandates

Compared to a vaccine with EUA status, a fully approved vaccine can instill confidence among the unvaccinated that the shots are both effective and safe. Full approval status also makes it easier for the federal and local governments to mandate vaccinations. A definite authorization can help take down misinformation about the vaccine’s efficacy and clarify legal issues surrounding mandates. 

The manufacturers of the Pfizer-BioNTech vaccine applied for full approval last May 7. However, there seems to be little sense of urgency coming from the FDA to streamline the process.

As a result, federal regulators are now under public pressure to fully approve the Pfizer-BioNTech vaccine. According to Dr. Ashish Jha, dean of Brown University’s School of Public Health, FDA seems to be taking its time. “I just have not sensed a sense of urgency from the F.D.A. on full approval. And I find it baffling, given where we are as a country in terms of infections, hospitalizations, and deaths,” said the dean. 

58% of Americans Vaccinated

Despite the availability of vaccines throughout the country, only 192 million Americans, or 58% of the total population and 70% of American adults, have received at least one inoculation.

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Many, including those already vaccinated, remain vulnerable to the highly contagious and dominant Delta strain. Within two weeks the US is now averaging 86,000 new infections a day. This represents an increase of 142% during the two-week period. 

Meanwhile, a Kaiser Family Foundation survey reported that three of every 10 unvaccinated Americans will be more willing to get vaccines if they carry an FDA full approval.

However, the survey cautioned that respondents likely do not understand the approval process. As a result, they might be looking at technicalities as justification for not choosing inoculation. 

Other Vaccines Also Want Full Approval

Apart from the Pfizer-BioNTech vaccine, other companies with EUAs also filed for full approval. Moderna filed for approval for its vaccine last June 1. However, the company is still submitting the required data and is unsure when it can finish doing so. Johnson & Johnson, the third vaccine to receive a EUA, plans to file for approval later this year.   

Once a product like the Pfizer-BioNTech vaccine receives full approval, many agencies can issue mandates calling for mandatory vaccination.

Government branches like the US Military continue to resist implementing a vaccine mandate until the FDA issues full approval among the many brands available. To fast-track the process, the FDA will need to quicken the pace in reviewing hundreds of thousands of pages of documents, which is around 10 the documentation needed to authorize a vaccine. The FDA estimates a typical approval process between six to eight months. 

Don’t Go Too Fast In Approving Vaccines

However, there are those who caution against speedy approvals. Dr. Peter Marks, the agency’s top vaccine regulator, warned against too much haste. Speeding up the approval process ”would undermine the FDA’s statutory responsibilities, affect public trust in the agency and do little to help combat vaccine hesitancy.”

If anything, regulators prefer to see real-world data for the Pfizer-BioNTech vaccine beginning at the time of emergency approval. Efficacy and immune responses might manifest themselves in due time, hence the need for extended study of data. Regulators also want to find out how immunity can decline over time and if they work on new virus variants.

Watch the Bloomberg Quicktake: Now report saying that the US Covid surge steps up pressure on FDA to Approve Pfizer-BioNTech Vaccine:

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2 Comments

2 Comments

  • Pogo says:

    There are already too many adverse reactions including death to rush. Look at all the drugs the agency has removed because of problems and because the drug companies failed to disclose health problems caused by their creations. They are not in it just to be good corporate citizens Remember follow the money they are making BILLIONS

  • Kim says:

    The rush approval process will only work to increase the vaccine hesitancy. Pressure from the government undermines the process and will only discredit the FDA, no one trusts or believes the CDC anymore. They have lost all creditability.
    GOD BLESS AMERICA!

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