WEATHER ALERT
Top vaccine official resigns from FDA, criticizes RFK Jr. for promoting 'misinformation and lies'
Read full article: Top vaccine official resigns from FDA, criticizes RFK Jr. for promoting 'misinformation and lies'The top vaccine official with the Food and Drug Administration has resigned and criticized the nation's top health official for allowing “misinformation and lies” to guide his thinking behind the safety of vaccinations.
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.
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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.
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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.
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Watch live: Dr. Fauci, federal health officials testify before Senate committee on efforts to combat COVID-19
Read full article: Watch live: Dr. Fauci, federal health officials testify before Senate committee on efforts to combat COVID-19Federal health officials including Dr. Anthony Fauci, the United States’ top infectious disease expert, are expected to give U.S. Senators an update on the efforts to combat COVID-19 in a hearing on Tuesday morning.
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US recommends ‘pause’ for J&J vaccine over clot reports
Read full article: US recommends ‘pause’ for J&J vaccine over clot reportsThe 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.
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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.
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J&J asks US regulators to OK its one-shot COVID-19 vaccine
Read full article: J&J asks US regulators to OK its one-shot COVID-19 vaccineThis July 2020 photo provided by Johnson & Johnson shows a vial of the Janssen COVID-19 vaccine. On Thursday, Feb. 4, 2021, Johnson & Johnson has asked U.S. regulators to clear the worlds first single-dose COVID-19 vaccine, an easier-to-use option that could boost scarce supplies. (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. J&J also is studying a two-dose version of its vaccine, but results won’t be available for several more months.
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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.
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Vaccine experts want the FDA to commit to 30,000 people in Covid-19 vaccine trials
Read full article: Vaccine experts want the FDA to commit to 30,000 people in Covid-19 vaccine trialsThe director of the National Institutes of Health has already said there needs to be 30,000 participants in the Phase 3 clinical trials. "Each vaccine needs to be tested on about 30,000 volunteers," Dr. Francis Collins told CNN. Some vaccine experts worry that even if a company intends to enroll those numbers, the Trump administration will prematurely approve their vaccines before their trials are over. Phase 3 trials vary in sizePhase 3 trials can vary in size. CNN reached out to all six companies asking what size they planned for their Phase 3 trials.