Author: Cailyn Schiltz
Pfizer’s early data reports that their vaccine could be 90% effective at preventing COVID-19. The company is planning on filing an emergency use application with U.S. regulators later this month.
“We’re in a position potentially to be able to offer some hope,” Dr. Bill Gruber, Pfizer’s senior vice president of clinical development, told The Associated Press. “We’re very encouraged.”
An independent data monitoring board analyzed Pfizer’s data and found only 94 mild infections of the 44,000-person study. This announcement does not promise a vaccine anytime soon though, according to Channel 3000.
Pfizer will continue the study until 164 participants contract the novel coronavirus; then they can see if infections were more common amongst participants who received the placebo rather than the actual vaccine. The Food & Drug Administration will only approve a vaccine that is at least 50% effective.
The FDA also needs these studies to include people who are more vulnerable to the novel coronavirus, such as racial minorities, older people and those with chronic illnesses.
The FDA also requires that Pfizer stay in contact with participants two months after the initial injection to monitor side effects. Pfizer will officially hit that mark later in November, but has not reported any serious safety concerns as of Monday.
Even if this vaccine gets the emergency use approval, Pfizer will have to figure out how to manufacture, ration, and distribute millions of doses around the world.
There are more remaining unknowns at this time. Pfizer has yet to discover if people who receive the vaccine could still asymptomatically carry and spread COVID-19. So far, they have only been testing participants who show symptoms.
If this vaccine meets the FDA standards, it will be the first vaccine using messenger RNA to be approved for use in humans and widely distributed. Messenger RNA (mRNA) is a single strand genetic material that gives the body instructions on how to build protein structures. Most vaccines inject a weakened version of a virus into the body so it will build antibodies to fight the disease, giving immunity after a small outside exposure. On the other hand, mRNA vaccines inject messenger RNA strands into the body rather than any actual viral proteins. An mRNA vaccine essentially instructs the body on how to build the viral proteins itself, leading to a vaccinated individual having antibodies and being immune without needing any actual outside exposure.
This is a developing story and WSUM will continue to track the effects of COVID-19 in communities.