Covid-19 roundup: Emergent's error costs J&J a vaccine batch; Pfizer head says EU restrictions slow vaccine distribution process
J&J has run into a snag in production of its Covid-19 vaccine after its quality patrol spotted problems with one batch of drug substance.
The issue — which the New York Times reported was due to a mix-up between the vectors used in J&J and AstraZeneca’s vaccines — sent J&J into trouble-shooting mode. The company said it’s sending additional experts in manufacturing, technical operations and quality to supervise onsite at Emergent’s Bayview facility, which was once touted for its capacity to rapidly scale manufacturing.
In a statement, J&J didn’t confirm whether the batch would indeed translate to 15 million doses, as the Times reported. It instead emphasized that the Emergent site has not yet been authorized by the FDA to make the active ingredients of its one-shot, adenovirus vector-based vaccine, and that it’s on track to deliver a total of 1 billion doses by 2021.
But while a board member has previously predicted they would deliver a total of 100 million doses to the US by April, J&J is now pushing that goal to the end of May. Through April, they expect to have 24 million doses, on top of the 20 million already in arms.
“This batch was never advanced to the filling and finishing stages of our manufacturing process,” the company added. “This is an example of the rigorous quality control applied to each batch of drug substance.”
Emergent, which had inked a $480 million deal to supply J&J’s Covid vaccine for the next two years, had been known as the maker of an anthrax vaccine prior to the pandemic.
Billed as a center for innovation in advanced development and manufacturing (CIADM), the Bayview site was built as part of a partnership with BARDA to speed development and production of vaccines or treatments for pandemic response.
Pfizer head says EU restrictions slow vaccine distribution process
The European Union has seen a shortage in Covid-19 vaccine availability, and Pfizer head Danny Hendrikse wants it to be known that new EU restrictions won’t make ending that shortage any easier.
The VP of global supply spoke out against new EU rules about the free movement of goods across borders, saying that it made it more difficult for the company to export the vaccine.
“Ultimately what we would like our colleagues to do is to focus on making and distributing the vaccine,” he told the UK’s Telegraph. “The components don’t just come from Europe, but from all over the world.”
Pfizer told EU leaders that the amount of time it takes to make the vaccine has been cut in half from 110 days to 60, thanks to an increase of production at its Belgium plant. But that batch is started in the US, with DNA plasmids.
The news comes on the back of Germany’s suspension of the AstraZeneca vaccine for patients under the age of 40 due to a rare, but fatal, blood clot called venous thrombosis. The clot was particularly present in young women, a report said. EU’s medical regulator said that there was no evidence to support the decision to stop using the vaccine, however.
Pfizer and BioNTech confirm high efficacy, no serious safety concerns after second Covid-19 vaccine dose
Six months after Pfizer and BioNTech’s Phase III clinical trial participants received the second dose of their Covid-19 vaccine, the companies have announced that there are no serious safety concerns.
Of the 927 confirmed symptomatic cases, 850 of the cases were in the placebo group and 77 were in the group given BNT162b2, good for a vaccine efficacy of 91.3%, according to a release. Six-month results also showed 100% efficacy in preventing severe disease.
Vaccine safety has now been evaluated in 44,000 participants ages 16 and up. Scientists have deemed the vaccine 100% effective in South Africa, where the B.1.351 variation is prevalent.
“The high vaccine efficacy observed through up to six months following a second dose and against the variant prevalent in South Africa provides further confidence in our vaccine’s overall effectiveness,” Pfizer CEO Albert Bourla said in a statement.
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