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Pfizer covid-19 vaccine will face the review of FDA panel. What will happen next?

via:cnBeta.COM     time:2020/12/11 8:01:28     readed:866

According to foreign media reports,The FDA's Vaccine Advisory Committee will meet on Thursday local time to discuss whether it should recommend approval of Pfizer's covid-19 vaccine emergency use authorization (EUA).This is an important milestone in seeking to slow down the new crown pandemic, but even if the Advisory Committee on vaccines and related biological products (vrbpac) gives Pfizer and biontech's bnt162b2 a green light, it does not mean that it will be automatically introduced to hospitals and medical institutions.

In fact, although vrbpac is an essential part of the EUA process for vaccines, it is only one step in the FDA's deployment path. "We recognize the urgent need for medical measures to diagnose, treat, and prevent this new virus, and have been working to promote its development and availability," FDA director Dr. Stephen Hahn said in a statement on Thursday. "In particular, the FDA has been working with the public and private sectors to promote the rapid development of the covid-19 vaccine without sacrificing our rigorous scientific standards for safety and effectiveness."

The committee itself is composed of independent public health and scientific experts. Earlier this week, the FDA released documents for today's hearing, including some preliminary insights into the efficacy and potential side effects of bnt162b2. With the conclusion of the hearing, vrbpac will issue recommendations to the FDA, but the agency has no obligation to adopt them.

"After the vrbpac meeting, FDA professionals will take into account the committee's comments, and they will continue to review the EUA request to determine whether it meets the safety and effectiveness criteria for issuing the EUA, and to improve the instructions and information provided to vaccinees," Hahn explained.

For the FDA, it is a difficult balance between the need for vaccination and concerns and doubts about the safety of such drugs. The CDC confirmed that novel coronavirus pneumonia cases were diagnosed in 15 million cases this week, with more than 285 thousand deaths in. With no signs of slowing down, insistence on social distance, masks and other precautions across the United States is at best sporadic, with experts warning that there is little sign of the new coronavirus slowing down in a short period of time without major intervention.

Similarly, the FDA is well aware that the EUA process cannot be rushed. "I can assure you that no vaccine will be licensed for use in the United States until FDA professional officials are confident that their families will receive the vaccine." Hahn insisted.

Pfizer's drug has begun to be deployed in the UK, where regulators approved the vaccine earlier this month. The pharmaceutical company said it expected to have the manufacturing capacity to supply up to 50 million doses of vaccines to the world by 2020 and 1.3 billion doses by the end of 2021. It also developed a special transport system, which it said would bypass concerns about the need for bnt162b2 to be transported and stored at extremely low temperatures, using GPS enabled thermal sensors to ensure overall stability.

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