Pfizer Seeks FDA Approval for Vaccine



A Record-Breaking Vaccine Development Process

On Friday, Pfizer (PFE) asked US health regulators to allow the use of its COVID-19 vaccine. This marks a significant milestone in the race to find a way to stop the virus which has taken over one million lives and caused economic upheaval around the world. Last week, Pfizer and its vaccine development partner BioNTech (BNTX) shared that their two-shot vaccine proved safe and 95% effective in a 44,000-person trial.

The FDA is expected to conduct the review process quickly given how impactful a COVID-19 vaccine would be. However, the health regulators have also emphasized that they will hold the vaccine to a high standard to ensure that it is safe for millions of people to receive.

Looking Ahead

Pfizer shared that distribution could begin as soon as mid-December, which would make this one of the fastest vaccine development efforts ever. Typically the process of researching, creating, and testing a vaccine takes at least 10 years. However, the stakes of finding a COVID-19 vaccine could not be higher, and researchers are rising to the challenge of finding a safe, effective shot in record time.

If and when the FDA approves the vaccine, there will be more hurdles to clear, from manufacturing and transporting shots to assuring the public that the shot is safe. It is possible that certain sectors of the population who are vulnerable to the virus, like healthcare workers and elderly citizens, would receive the vaccine first.

Other Developments in the Fight Against COVID-19

Health experts are also reviewing products for fighting COVID-19 developed by other companies. On Friday, the World Health Organization recommended against the use of Remdesivir, a drug for treating the virus developed by Gilead (GILD). Gilead has contested the claims and the FDA approved Remdesivir as a way to treat COVID-19 patients in October. Last week the FDA also granted emergency use authorization for baricitinib, a drug developed by Eli Lilly (LLY), used to help patients recover from COVID-19.

Moderna (MRNA) has also reported positive results from its COVID-19 vaccine trial. After the company finishes gathering safety-related data, it plans to seek FDA authorization in a matter of weeks.


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