FDA Asks J&J, AstraZeneca For Safety Review After Plant Contamination
The Food and Drug Administration says it can't rule out a low-level risk of cross-contamination between the two vaccines manufactured by contractor Emergent BioSolutions. In other vaccine news from the Biden administration: the White House science adviser looks to the next pandemic's salvation and a CDC decision hamstrings investigations of breakthrough infections.
Politico:
Biden Admin Probes Risk Of Low-Level Contamination In Vaccines Made At Troubled Plant
The Food and Drug Administration has asked Johnson & Johnson and AstraZeneca to assess any potential health risks from minor cross-contamination of their Covid-19 vaccines, two people familiar with those conversations told POLITICO. The agency requested the analyses because it cannot rule out low-level contamination of doses of both vaccines manufactured by contractor Emergent BioSolutions. (Banco, 6/2)
AP:
Science Chief Wants Next Pandemic Vaccine Ready In 100 Days
The new White House science adviser wants to have a vaccine ready to fight the next pandemic in just about 100 days after recognizing a potential viral outbreak. In his first interview after being sworn in Wednesday, Eric Lander painted a rosy near future where a renewed American emphasis on science not only better prepares the world for the next pandemic with plug-and-play vaccines, but also changes how medicine fights disease and treats patients, curbs climate change and further explores space. He even threw in a “Star Trek” reference. (Borenstein, 6/2)
NPR:
CDC Move To Limit Investigations Into COVID Breakthrough Infections Sparks Concerns
The Centers for Disease Control and Prevention has stopped tracking every case that occurs when a COVID-19 vaccine fails to protect someone. Instead, the agency is focusing on people who get very sick or die. The decision is controversial. Critics argue the strategy could miss important information that could leave the U.S. vulnerable, including early signs of new variants that are better at outsmarting the vaccines. The CDC and outside infectious disease experts, however, say it makes sense to prioritize efforts on those who get hospitalized or die. (Stein, 6/2)
In other news about vaccine development and manufacturing —
The New York Times:
AstraZeneca In Talks To Switch Factories For Vaccine Production For U.S. Government
The British-Swedish company AstraZeneca is negotiating with the federal government to shift production of its coronavirus vaccine from a troubled plant near Baltimore to a factory owned by the pharmaceutical company Catalent, according to people familiar with the government’s plans. Catalent already produces AstraZeneca’s vaccine for export at a factory in Harmans, Md., south of Baltimore. It is now in discussions to retrofit a production line there to make the vaccine for the federal government, taking over for Emergent BioSolutions, which was forced to stop manufacturing AstraZeneca’s vaccine more than six weeks ago after a major production mishap. (Weiland, LaFraniere and Stolberg, 6/2)
Louisville Courier-Journal:
Norton To Test COVID-19 Pfizer Vaccine In Kids As Young As 6 Months
Louisville researchers announced Wednesday they will study the Pfizer vaccine in children ages 6 months to 11 years as part of a larger trial that seeks to expand eligibility. The Norton Children’s Research Institute, affiliated with the U of L School of Medicine, will look at the safety of the vaccine in children and how their bodies respond to it. Norton plans to enroll its first patients in the next week or two. (Ladd, 6/2)
AP:
Vaccine Protection May Diminish Need For Yearly Boosters
Scientists have found clues that the world’s leading COVID-19 vaccines offer lasting protection that could diminish the need for frequent booster shots, but they caution that more research is needed and that virus mutations are still a wild card. Critical studies are underway, and evidence is mounting that immunity from the mRNA vaccines made by Pfizer and Moderna does not depend exclusively on antibodies that dwindle over time. The body has overlapping layers of protection that offer backup. (Neergaard, 6/2)