FDA, CDC end the pause on the J&J vaccine

Soon after the CDC’s Advisory Committee on Immunization Practices voted 10-4 (with one abstention) on Friday (April 23) to recommend ending the pause put on the J&J vaccine. FDA and CDC officials quickly yesterday to follow the recommendation.

The agencies said the risk (15 cases of blood clots with low platelet levels — the medical term is thrombosis-thrombocytopenia syndrome — out of 7.98 million people vaccinated) outweighed the benefits of reducing deaths and hospitalizations from COVID-19.

The advisory committee heard a presentation on Friday that calculated that the J&J vaccine might (it is just a projection, built on assumptions) result in 26-45 cases of blood clots over six-month period if the vaccine is administered to adults ages 18 and older. The offsetting benefit, according to CDC projections, would be between 600 and 1,400 fewer deaths and between 800 and 3,500 fewer ICU admissions. Here is summary slide from that presentation by Sara Oliver, M.D.,a CDC scientist:

The CDC Director: Pregnant women should get vaccinated

At the press briefing Friday (April 23) by the White House COVID-19 Response Team and other public health officials, CDC Director Rochelle Walensky, M.D., urged pregnant women to get vaccinated. Walensky referenced findings reported in the New England Journal of Medicine on Wednesday (April 21) by the CDC scientists that showed no additional adverse pregnancy or neonatal adverse events among pregnant women vaccinated with the Pfizer or Moderna vaccines.

“Pregnant people experienced the same side effects as others following vaccination,” Walensky said during the briefing according to a White House transcript. “We were also able to follow, in detail, more than 3,900 pregnant women, and over 800 of whom have completed their pregnancies. Importantly, no safety concerns were observed for people vaccinated in the third trimester or safety concerns for their babies.

“As such, CDC recommends that pregnant people receive the COVID-19 vaccine. We know that this is a deeply personal decision, and I encourage people to talk to their doctors or primary care providers to determine what is best for them and for their baby.” 

Some signs that demand is plateauing

The Associated Press reported yesterday (April 23) that Louisiana has stopped asking for its full allotment of vaccine and that about three-quarters of the counties in Kansas have turned down shipments at least once this month. “Even as states expanded eligibility beyond the initial priority groups, the upward trend in getting shots in arms is stalling, especially in the South and the Mountain West,” the Wall Street Journal reported today

Not 100% protection: Breakthrough infections reported at Rockefeller University…

Researchers at Rockefeller University in New York City reported the occurrence of two breakthrough infections among the 417 faculty and students at the biomedical research university who were vaccinated earlier this year. According to their report in the New England Journal of Medicine on Wednesday (April 21), one occurred in a 51-year-old woman who had been vaccinated with the doses of Moderna vaccine and the other in 65-year-old woman who had received the Pfizer vaccine. Both patients had symptoms but recovered at home. The 51-year-old woman was infected with a variant that is related to the U.K. (B.1.1.7) and New York City (B.1.526) variants. She had both a high viral and have antibody levels, and the Rockefeller researchers said her case is indication that infections with variants can produce high viral loads despite high levels of antibodies.

…and among residents and staff at nursing homes in Chicago

On the same day (April 21) as the report in NEJM, team of researchers from the CDC and the Chicago Department of Public Health reported that 12 residents and 10 staff members at nursing homes in the city had at the facility had breakthrough infections — they tested positive for SARS-CoV-2 after receiving a second COVID-19 vaccine dose (the vaccine was not identified). According to their report in the Morbidity and Mortality Weekly Report, 14 were asymptomatic and no facility-associated secondary transmission was detected. Two residents with breakthrough infections experienced COVID-related hospitalizations, one of whom died because of multiple concurrent infections.

FDA cites J&J supplier for cleanliness, quality control shortfalls

The FDA cited Emergent BioSolutions, a J&J subcontractor, on Wednesday (April 21) for failure to thoroughly cross contamination issues and for unsanitary issues at its plant in Baltimore. The inspection report, which has some of the details redacted, says cross contamination of “viral vaccine drug substance batch” has not been thoroughly investigated and that “there are no assurances that other batches have not been subject to cross-contamination. The FDA’s public statement on the inspection said that company had agreed to pause new production while it works with the agency to resolve “potential quality issues.” The statement said that any vaccine that has already been manufactured will undergo additional testing.

Biden plugs tax credit for employers who offer paid leave for vaccination, side effects

Employers can claim COVID-19-related tax credits under American Rescue Plan Act if they provide paid leave for employees to get vaccinated and for recovering from any side effects of the shots, President Biden announced on Wednesday (April 21). The IRS posted a factsheet about the tax credits on the same day. The credit tops out at $511 per day and $5,110 in aggregate.

Colleges move to require the jab

It is difficult getting into an Ivy League. Now some are adding COVID-19 vaccinations to attend. Columbia and Yale announced the requirement on Monday (April 19)and Princeton followed suit on Tuesday. Cornell and Brown officials had previously announced that they were requiring students to be vaccinated. CNBC reported yesterday that more than 30 colleges and universities have now imposed vaccine requirements.