New blood donation rules allow more gay men to give in US
New blood donations rules will allow sexually active gay and bisexual men in monogamous relationships to give in the U.S. The Food and Drug Administration guidelines ease decades-old restrictions on blood donations put in place to protect the blood supply from HIV.
The Latest: Mexico receives shipment of Sputnik V vaccine
A medical worker prepares a shot of Russia's Sputnik V coronavirus vaccine in a local rural medical post in the village of Ikhala in Russias Karelia region, Tuesday, Feb. 16, 2021. (AP Photo/Dmitri Lovetsky)MEXICO CITY โ Mexico has received its first shipment of Russiaโs Sputnik V COVID-19 vaccine. Mexico received its first shipment of vaccines from Pfizer in mid-December, but turned to Sputnik V in January when other expected vaccine shipments were delayed. The company reiterated that it will have capacity to provide 100 million vaccine doses to the U.S. by the end of June. ___WASHINGTON โ The White House now says it expects to catch up by mid-week on deliveries of coronavirus vaccine doses that were delayed by severe weather.
Johnson & Johnson asks US regulators to OK its one-shot COVID-19 vaccine
This Sept. 2020 photo provided by Johnson & Johnson shows the investigational Janssen COVID-19 vaccine. Johnson & Johnson's long-awaited COVID-19 vaccine appears to protect against symptomatic illness with just one shot not as strong as some two-shot rivals but still potentially helpful for a world in dire need of more doses. Johnson & Johnson said Friday, Jan. 29, 2021 that in the U.S. and seven other countries, the first single-shot vaccine appears 66% effective overall at preventing moderate to severe COVID-19. (Cheryl Gerber/Johnson & Johnson via AP)Johnson & Johnson asked U.S. regulators Thursday to clear the worldโs first single-dose COVID-19 vaccine, an easier-to-use option that could boost scarce supplies. J&Jโs vaccine was safe and offered strong protection against moderate to severe COVID-19, according to preliminary results from a massive international study.
FDA addresses COVID vaccine concerns in news briefing: What to know
In a rare weekend press conference, the U.S. Food and Drug Administration (FDA) -- who is responsible for authorizing widespread use of Pfizerโs coronavirus vaccine on Friday -- discussed some of peopleโs biggest concerns about the vaccine. Amid two recent cases of allergic reactions to Pfizerโs coronavirus vaccine in the U.K., FDA officials addressed concerns about individuals with a history of allergic reactions receiving the vaccine. FDA officials said Saturday that theyโve followed that process when reviewing Pfizerโs vaccine, and they feel confident that it is safe for this age group to receive the shots. During Saturdayโs news briefing, officials made it clear that pressure from the White House did not force the FDA to authorize use of the vaccine too early. More: Report: White House to FDA chief: Approve Pfizer vaccine Friday or quitโWeโre going to maintain the integrity of the scientific process,โ Hahn added.
Hereโs a look at FDAโs COVID-19 vaccine review process
Scientists with the U.S. Food and Drug Administration (FDA) are working to review two COVID-19 vaccines submitted by drug companies Pfizer and Moderna. Pfizer submitted its application on Nov. 20 for an emergency use authorization to the FDA Center for Biologics Evaluation and Research (CBER). โThe safety profile of a vaccine thatโs going to be deployed in millions of people has to be incredibly clean,โ said Dr. Peter Marks, who directs CBER. โWe, as an agency, are one of the last agencies in the world that we still actually get the primary data. We donโt get summary data.โCBER receives raw data on all participants in a vaccine trial, in addition to volumes of information on every aspect of the vaccine.
How the FDA is working to make sure any COVID-19 vaccine would meet their standards for safety
DETROIT โ The New York Times reports top White House officials have blocked stricter federal guidelines proposed for the emergency authorization of any coronavirus vaccine. The Food and Drug Administration is working to make sure any vaccine would meet or exceed their standards for safety. Dr. Peter Marks is the director of the FDA center that will ultimately authorize or reject a vaccine. According to the Post, Marks in his current role is the highest-ranking career official involved in the approval of any potential vaccine candidate. If historical precedent holds true, that means Marks, rather than a political appointee, ultimately will be tasked with recommending for or against FDA approval of any potential vaccine.
FDA publishes vaccine guidelines opposed by White House
In the new guidelines posted on its website, the FDA said vaccine makers should follow trial participants for at least two months to rule out any major side effects before seeking emergency approval. That standard had been a sticking point between the FDA and White House officials, who said it could unreasonably delay the availability of COVID-19 vaccines. On Monday Trump said vaccines are coming โmomentarily,โ in a video recorded after he returned to the White House. The White House attempt to block the guidance followed a string of instances in which the Trump administration has undercut its own medical experts working to combat the pandemic. Beyond exposing the rift between the White House and FDA, the delay in releasing the guidelines may have had limited practical effect.