FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate

In the last two weeks, a flurry of news over new promising vaccines showed an optimum 95% effectiveness. Pfizer allied with the Germany’s BioNTech SE, developed a new Covid-19 vaccine shot that was confirmed to be 95% effective in a final analysis of trial data, now have applied for an Emergency Use Authorization from the U.S. regulatory clearance for vaccine.

Similarly, Moderna’s Covid-19 vaccine appears equally effective, showing 94.5% effectiveness, plans to seek EUA from FDA soon. Another frontrunner vaccine from the University of Oxford confirmed that their new Covid-19 vaccine that has developed with the AstraZeneca Plc, in an early study, generated strong immune responses in older adults.

Therefore, U.S. Food and Drug Administration has planned to schedule a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 10 to discuss the request for emergency use authorization (EUA) of a COVID-19 vaccine from Pfizer, Inc. in partnership with BioNTech Manufacturing GmbH. However, on Friday, Pfizer released a statement that they had submitted an application to the Food and Drug Administration to seek EUA for their Covid-19 vaccine. They plan to set in motion the regulatory process that could allow the first Americans to get a vaccine by the middle of December.

This particular type of genetic material is used to program a human cell in a way that it destroys all the potential copies of a fragment of the virus. An emergency authorization would allow easy access of the vaccines, yet, FDA made clear that their through new guidelines the bar for emergency authorization will be high.

On July 27, both the vaccine candidates are shortlisted after running large human trials, leading the pack of six federal funded vaccines, Operation Warp Speed. It is hoped that if both vaccines got the EUA, it would be easier to develop sufficient amount of dose to immunize over 20 million Americans including healthcare workers and people living in nursing homes before the end of this year, because in U.S. an estimated 17 million to 20 million health care workers and about a million people are living in nursing homes. Nonetheless, it is hoped that by next year, companies will be able to ramp up the manufacturing process to provide vaccines to millions of people around the globe.

Similar to other vaccines, mass production of these two vaccines for the Covid-19 is quite complex because of its sterile as well as storage conditions, since the storage temperature conditions for these vaccines are quite low, sensitive, and hard to achieve.

Moreover, the vaccine is required to be refrigerated at -70 to -80 degrees for effectiveness, whereas in most hospitals, the storage conditions for vaccine distribution and storage are around -2 to -8 degrees. At this temperature, the vaccine will spoil after five days. However, Pfizer spokeswoman Kim Bencker said that the company was working closely with the state officials and U.S. government on how to ship the vaccine from its distribution centers situated in the United States, Germany and Belgium. They planned to use the dry ice to transport the frozen vaccine vials by both air and land and the recommended temperatures was for up to 10 days.

“The cold chain is going to be one of the most challenging aspects of delivery of this vaccination,” said Amesh Adalja, senior scholar at Johns Hopkins Center for Health Security.

Source: Reliefweb

Notably, the mRNA technology for vaccine has never been commercially manufactured before. Regardless of these raised concerns, according to the federal officials, it is expected that nearly hundreds of millions of doses could be available by the spring. Additionally, both Pfizer and Moderna, decided with the government that vaccines should be made free for Americans.

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