FDA Says Covid Vaccine Makers Can Modify Shots As Variants Emerge


The Food and Drug Administration has laid the groundwork for drugmakers to be able to react quickly to emerging coronavirus variants and get modified products to the public without the need for extended clinical trials. "We are using every tool in our toolbox to fight this pandemic, including pivoting as the virus adapts," Dr. Janet Woodcock, acting FDA commissioner, said in a statement Monday. The FDA guidance issued Monday is for companies that make Covid-19 vaccines, therapeutics and diagnostic tests as they work to keep up with evolving variants of SARS-CoV-2. Evidence so far suggests that the two Covid-19 vaccines authorized in the U.S., from Moderna and Pfizer-BioNTech, appear to offer good protection against new variants. But the fact that the virus continues to mutate means drugmakers will need to keep up, adapting quickly if necessary. The FDA guidance suggests companies may be able to pull back on lengthy clinical trials to prove safety and effectiveness each time a new variant emerges. This is not unlike how the flu shot changes from year to year. "For influenza, we are so accustomed to doing this," Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said on a call with reporters Monday. Because the flu shot is so well studied, human clinical studies are unnecessary each year. Manufacturers simply modify the shots based on the strains that are predicted to be in circulation. Until experts have more data on Covid-19 vaccines, however, the FDA will continue to require drugmakers to study their vaccines' efficacy against emerging strains. "We need to understand whether the new vaccine strain is able to cover both the new strain and the old strain," Marks said. Additional safety data, at least in the interim, will be necessary. Hope it really is what the report says. The mutation of Covid-19 has brought more trouble to the current situation, and vaccine manufacturers must respond quickly to emerging coronavirus variants.

NB: Stories are shared by community members. The article does NOT represent the official view of NaijaWorld and the author is SOLELY RESPONSIBLE for this article

About Us
You can follow any community you find interesting, get your news, ask for advice, discuss sports, and voice your opinion. Upload photos, contribute stories, join discussions, and help other people find the best stories, videos, pics, games, and news by upvoting and downvoting posts. Share and discuss posts with other naijaworlders.
Related Stories
How To Make Scent Leaf Tea: Health Benefits And Side Effects
Zulum Offers Scholarships For Dikwa Health Workers, Teachers
Diri Approves Promotion For LG, Health Workers, Teachers
Health Workers In CRS To Own Houses, Dr Betta Edu Commends Ayade And MHWUN
Working Under Scorching Sun, Rain Affecting Our Health, Abia Traffic Wardens Cry
Cell Renewal And Regeneration Pills For Optimal Health Of Animal And Man
The Health Benefits Of Active Sex
Lions Club Partners CRSG, To Build Diabetic Centre And PHC In Cal South
Lagos Commences Refurbishment Of General Hospitals
Plant Based Diet For Beginners