The COVID-19 vaccine developed by Pfizer and BioNTech has been approved for emergency use. On Thursday the US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee voted 17 - 4 with one member abstaining.
Should the FDA sign off on the recommendation, as is expected, vaccines could begin to be administered within days. Pfizer says it will have around 25 million doses of the two phase vaccine ready for the U.S. by the end of December.
FDA scientists gave the vaccine great reviews earlier in the week. So far Pfizer’s ongoing study of 44,000 individuals has shown strong protection with people of varying ages, races, and health with no major safety problems.
Rollout Closely Monitored
There are still some unanswered questions however as the vaccine is still experimental and has yet to complete the final stage of its study. As an example, while the vaccine is over 90% effective in blocking COVID-19 symptoms, it is not yet entirely clear whether it can stop the silent, asymptomatic spread of the disease.
Also, the emergency use authorization only clears those who are at least 16 years old to receive the vaccine. According to the FDA, there is currently insufficient data to make conclusions regarding the safety of the vaccine for children under 16, pregnant women, and those with compromised immune systems.
U.S. officials will watch for any problems with the vaccine as it is rolled out. They will use “v-safe”, a text-messaging system, which will provide immediate indications about possible adverse reactions from the vaccine. Thus far only two people have had such reactions from the rollout in the United Kingdom.
Prioritised Expansion
The hope is the vaccine will be the first of several, eventually closing the door on a pandemic that has infected over 15 million Americans, killing 292 thousand. Today alone 3,055 deaths were reported, a number that has been steadily increasing nationwide. Worldwide nearly 70 million have been infected, with 1.58 million deaths.
Initial supplies will be limited for use primarily by health care workers and nursing home residents. Other vulnerable groups will be next in line when ramped up production allows the vaccine to be available at higher demand. This expansion may not occur until spring.
Priority during the expansion will be based primarily on age and health conditions, with elderly citizens receiving the vaccine before young, healthy adults. More testing is required before children and pregnant women will be allowed to take it. Those with a history of serious reactions to vaccines should not get it for now, highlighting the importance that those with the ability to take it do so for the sake of herd immunity.
A Hope to Move Past COVID-19
Experts estimate that at least 70% of the population will have to be vaccinated in order to achieve herd immunity. Only then will normalcy begin to return, and Americans able to put away their masks.
The FDA will review another vaccine, from Moderna and the National Institutes of Health, next week. This vaccine requires a storage of only -4 degrees Fahrenheit versus the more challenging -94 degrees Fahrenheit of the Pfizer vaccine. A third candidate from Johnson & Johnson should also be ready for review soon, this vaccine would require only one dose. Beyond that, a vaccine from AstraZeneca and Oxford University is also in the works.
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