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Morning Briefing

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Thursday, Jun 3 2021

Full Issue

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.

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)

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 鈥淪tar Trek鈥 reference. (Borenstein, 6/2)

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 鈥

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鈥檚 plans. Catalent already produces AstraZeneca鈥檚 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鈥檚 vaccine more than six weeks ago after a major production mishap. (Weiland, LaFraniere and Stolberg, 6/2)

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.聽The Norton Children鈥檚 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聽plans to enroll its first patients in the next week or two.聽(Ladd, 6/2)

Scientists have found clues that the world鈥檚 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)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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