After a two-month hold on millions of doses of the J&J vaccine, the FDA will announce that it is releasing 10 million doses and trashing 60 million that were made at a troubled Baltimore plant, The New York Times scooped on Friday morning.
Emergent BioSolutions reported that the doses were contaminated after drug material intended for the AstraZeneca vaccine came in close contact with media prepared for a J&J run. As a result, the doses were held from distribution, causing a shakeup in early availability.
Later, a Form 483 from the FDA revealed improper decontamination methods from staff and other unsanitary conditions like paint chipping on the walls and mold growing in the building.
Another 60 million doses of AstraZeneca’s could become available as well. The FDA has not determined whether Emergent can resume production again, several outlets reported. — Josh Sullivan
EMA updates AstraZeneca vaccine warnings, continues review of myocarditis and pericarditis for mRNA vaccines
The European Medicines Agency said Friday that it has concluded that people who have previously had capillary leak syndrome must not be vaccinated with AstraZeneca’s Covid vaccine Vaxzevria.
“The Committee carried out an in-depth review of 6 cases of capillary leak syndrome in people who had received Vaxzevria. Most of the cases occurred in women and within 4 days of vaccination. Three of those affected had a history of capillary leak syndrome and one of them subsequently died. As of 27 May 2021, more than 78 million doses of Vaxzevria had been administered in the EU/EEA and the UK,” EMA said.
The agency also said it’s continuing its review of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane around the heart) in a small number of people following vaccination with Covid vaccines, including the one from Pfizer.
As of the end of May 2021, cases of myocarditis reported in the EEA from Eudravigilance database were 122 (Pfizer’s Comirnaty), 16 (Moderna’s vaccine) and 38 (AstraZeneca’s Vaxzevria) and 0 for J&J. The exposure in the EEA for each vaccine was around 160 million doses for Comirnaty, 19 million doses for Moderna, 40 million for Vaxzevria and 2 million for Janssen.
And as of the end of May 2021, EMA said cases of pericarditis reported in the EEA database were 126 (Comirnaty), 18 (Moderna), 47 (Vaxzevria) and 1 (Janssen).
“For Comirnaty and COVID-19 Vaccine Moderna the PRAC is reviewing cases of myocarditis and pericarditis in the context of a safety signal, under an accelerated timetable (finalisation expected in July),” EMA said.
The CDC on Thursday, at an FDA advisory committee meeting on vaccinating children, also presented its findings on myocarditis and pericarditis following mRNA vaccination, noting 488 total reports for the Pfizer-BioNTech vaccine and 301 reports for Moderna through the end of May. CDC found that of the reports, the median age after the first dose was 30, and 24 for the second dose, with more males than females reporting myocarditis and pericarditis. CDC said 15 are still hospitalized and three are in the intensive care unit.
While the slides show no statistical signal yet, CDC’s ACIP has scheduled a meeting for next Friday to further update the data, and discuss its evaluation of myocarditis following mRNA vaccinations, as well as to assess the benefit-risk balance. — Zachary Brennan
Pfizer has emergency plan to produce another vaccine in months, if needed
During the G7 summit Thursday, Pfizer CEO Albert Bourla announced that if a new vaccine were needed, the company has a process to ensure it could be developed within 100 days. He also reinforced that according to his company’s data, none of the existing variant strains have escaped protection from the vaccine.
“I repeat: none,” he said. “Not one.”
Pfizer scientists are also pursuing an oral treatment against Covid-19, the initial results of which Bourla called “promising.” If things go according to plan, the company could apply for approval by the end of 2021.
The Group of Seven is expected to donate 1 billion Covid-19 vaccine doses to low-income countries, British Prime Minister Boris Johnson said Thursday.
The news came just a few hours after President Joe Biden announced that the US was set to donate at least 500 million Pfizer-BioNTech shots, Reuters reports. The group is expected to agree to the donation during the three-day summit at Carbis Bay in England.
England is expected to donate 100 million of those shots, 80 million of which will go to COVAX, Johnson has said.
Both countries have rolled out successful vaccination campaigns. Nearly 52% of the total US population, and 61.5% of adults have received at least one dose of the vaccine. In England, 77% of adults have received a jab.
But one billion doses may not be enough. Anna Marriott, the global poverty organization Oxfam’s health policy manager, said that if the best leaders can do is donate 1 billion doses, the summit will have been a failure. Marriott called for 11 billion doses to end the pandemic, and called for intellectual property waivers, Reuters reported. Nearly 4 billion people are dependent upon vaccines from COVAX, the program from Gavi, the vaccine alliance to provide shots to low- and middle-income countries.
The virus has led to the deaths of 3.9 million people since its start in China in 2019. — Josh Sullivan
Germany debates bailing on CureVac as the wait continues
German Health Minister Jens Spahn no longer plans to use CureVac’s Covid-19 vaccine for the current vaccination campaign, RP Online has reported.
EMA approval was originally expected by May, but on Tuesday news broke that regulatory approval of the vaccine shouldn’t be expected to come before August.
Chief production officer Florian von der Mülbe has blamed delays on supply chain issues. In July 2020, GSK announced it would invest $293 million in the jab and take on manufacturing responsibilities. — Josh Sullivan
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