INSIDER
Experimental treatment pushed by ALS patients gets day before FDA, but agency unconvinced it works
Read full article: Experimental treatment pushed by ALS patients gets day before FDA, but agency unconvinced it worksThe Food and Drug Administration meets this week to consider a much-debated treatment for Lou Gehrig’s disease.
New blood donation rules allow more gay men to give in US
Read full article: New blood donation rules allow more gay men to give in USNew 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.
US grapples with whether to modify COVID vaccine for fall
Read full article: US grapples with whether to modify COVID vaccine for fallU.S. health authorities are facing a critical decision: whether to offer new COVID-19 booster shots this fall that are modified to better match the latest changes of the shape-shifting coronavirus.
Pfizer vaccine for kids may not be available until November
Read full article: Pfizer vaccine for kids may not be available until NovemberPfizer has submitted research to the U.S. Food and Drug Administration on the effectiveness of its COVID-19 vaccine in children but the shots may not be available until November.
The Latest: Pfizer gives vaccine data from kids 5-11 to FDA
Read full article: The Latest: Pfizer gives vaccine data from kids 5-11 to FDAPfizer has submitted research to the U.S. Food and Drug Administration on the effectiveness of its COVID-19 vaccine in children as it moves closer to seeking approval for expanded use of the shots.
What the J&J COVID-19 vaccine rare blood clotting issues mean for people who recently got it
Read full article: What the J&J COVID-19 vaccine rare blood clotting issues mean for people who recently got itOn Monday, the Centers for Disease Control and Prevention in addition to the Food and Drug Administration made a recommendation to place a pause on giving the COVID-19 Johnson & Johnson vaccine.
US recommends 'pause' for J&J shots in blow to vaccine drive
Read full article: US recommends 'pause' for J&J shots in blow to vaccine driveThe U.S. recommendation to “pause” use of the single-dose Johnson & Johnson COVID-19 vaccine set off a chain reaction worldwide and dealt a setback to the global vaccine campaign.
The Latest: Mexico receives shipment of Sputnik V vaccine
Read full article: The Latest: Mexico receives shipment of Sputnik V vaccineA 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 — Mexico has received its first shipment of Russia’s 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 — 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
Read full article: Johnson & Johnson asks US regulators to OK its one-shot COVID-19 vaccineThis 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 world’s first single-dose COVID-19 vaccine, an easier-to-use option that could boost scarce supplies. J&J’s 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
Read full article: FDA addresses COVID vaccine concerns in news briefing: What to knowIn a rare weekend press conference, the U.S. Food and Drug Administration (FDA) -- who is responsible for authorizing widespread use of Pfizer’s coronavirus vaccine on Friday -- discussed some of people’s biggest concerns about the vaccine. Amid two recent cases of allergic reactions to Pfizer’s 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 they’ve followed that process when reviewing Pfizer’s vaccine, and they feel confident that it is safe for this age group to receive the shots. During Saturday’s 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 quit“We’re going to maintain the integrity of the scientific process,” Hahn added.
Here’s a look at FDA’s COVID-19 vaccine review process
Read full article: Here’s a look at FDA’s COVID-19 vaccine review processScientists 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). “The safety profile of a vaccine that’s going to be deployed in millions of people has to be incredibly clean,” said Dr. Peter Marks, who directs CBER. “We, as an agency, are one of the last agencies in the world that we still actually get the primary data. We don’t get summary data.”CBER 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
Read full article: How the FDA is working to make sure any COVID-19 vaccine would meet their standards for safetyDETROIT – 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
Read full article: FDA publishes vaccine guidelines opposed by White HouseIn 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 “momentarily,” 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.