Covid-19 roundup: EMA ups Pfizer, Moderna vaccine manufacturing capabilities amid shortage
As vaccine shortages have caused countries to scramble, supply chain shortages and even lawsuits, the EMA has approved an increase manufacturing at European facilities for both Pfizer-BioNTech and Moderna’s Covid-19 vaccines.
An increase in batch size at Pfizer’s Puurs, Belgium plant was approved, in an effort to successfully and safely ramp up production to increase the number of doses available. BioNTech CEO Ugur Sahin told Bloomberg TV last month that Pfizer and BioNTech could increase manufacturing capacity to produce 3 billion doses next year, and could create 2 billion by 2021’s end. CFO Sierk Poetting has also said that constructing new production sites to keep up with demand is possible.
A new manufacturing line was also approved for Moderna’s site in Rovi, Spain. The line will increase fill-finish capabilities to keep up with a scale-up process approved at Lonza’s Visp manufacturing site approved in March, according to a release.
Pfizer/BioNTech, Moderna vaccines clear more variant tests
Even as drugmakers race to develop new versions of Covid-19 vaccines tailored to emerging SARS-CoV-2 variants, Pfizer/BioNTech and Moderna’s original jabs continue to look good enough for these new virus strains.
In the latest example, the mRNA vaccines have cleared preliminary tests against the New York variant, or B.1.526, according to two preprints posted Thursday. While scientists found a reduction of neutralization titers in vaccine-elicited antibodies when presented with pseudoviruses that have mutated spike proteins, they note that the antibodies are still enough to neutralize the variants.
The new results add to earlier evidence suggesting that the vaccines are effective against the South African and UK variants.
The takeaway? Get vaccinated, with monitoring variants and how they affect vaccine and antibody efficacy.
“The findings suggest that current vaccines and therapeutic monoclonal antibodies will remain protective against the B.1.526 variants,” read a study from the NYU Grossman School of Medicine and NYU Langone Vaccine Center, referring to Pfizer/BioNTech and Moderna’s vaccines as well as Regeneron’s antibody cocktail.
Compared to the wild type spike protein, vaccine-elicited antibodies still neutralized a pseudovirus with a E484K mutated spike protein but sported “a modest 3.5-fold decrease in titer,” they added.
The other study, conducted by a coalition in New York, Boston and California, noted that a “B.1.526 pseudovirus had a statistically significant reduced neutralization titer compared to the D614G control: for vaccinee plasma, 4.5-fold reduced (p = 0.00005).”
“We’re not seeing big differences,” Michel Nussenzweig, an immunologist at Rockefeller University in New York who was involved in that second study, told the New York Times.
EU seals supply deal for 1.8B Pfizer/BioNTech doses while snubbing J&J, AstraZeneca — report
The EU has reportedly sealed its third contract with Pfizer and BioNTech, clinching the supply of 1.8 billion doses over the next couple of years while declining to take up the extra 300 million doses it’s previously reserved from AstraZeneca and J&J.
Reuters cited senior officials in reporting both moves. Amid longstanding tension with AstraZeneca and investigations on the safety of J&J’s vaccine, the European bloc has openly put its faith in the mRNA vaccine, with EC president Ursula von der Leyen offering a public shoutout to Pfizer-BioNTech and praising the two companies as a “reliable partner” that delivers on its commitments.
So far, the EU has ordered 300 million from AstraZeneca and 200 million doses from J&J, with the options to purchase an additional 100 million and 200 million, respectively.
“There is no need to exercise the options” for those extra doses, an official directly involved in talks with vaccine makers told Reuters.
Here’s what a PhIII trial for a second-gen Covid-19 vaccine looks like
French vaccine maker Valneva has officially made the leap to Phase III with its Covid-19 vaccine candidate. But it may look a bit unfamiliar.
Instead of enrolling tens of thousands of volunteers and giving half of them placebos to tease out the protective effect of its vaccine, Valneva’s pivotal trial will involve around 4,000 participants. They will receive either two shots of either VLA2001 or Vaxzevria, AstraZeneca and Oxford’s conditionally approved vaccine. Investigators will then compare the immune responses (i.e. antibody titers) elicited by each of the jabs, with an eye to superiority.
While Valneva suggested that the trial results, if positive, would support regulatory approval in the UK, they wouldn’t be enough for an emergency use authorization in the US based on current FDA requirements. AstraZeneca’s shot isn’t currently cleared for use in the US.
Notably, Valneva is going with a 4-week regimen. AstraZeneca has suggested that its adenovirus-based vaccine is more effective when given 12 weeks apart.
The only European player to test an inactivated vaccine — a popular approach in China — Valneva has struck a supply deal with the UK, where the trial will take place, and is manufacturing its shots in Scotland.
“We believe that VLA2001 has an important role to play including boosters or potential modifications to the vaccine to address variants,” CEO Thomas Lingelbach said in a statement. “While Cov-Compare is progressing we are planning to conduct additional, complementary trials.”
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