Covid-19 roundup: US to donate 20M more vaccines overseas; BerGenBio hopes for the best after repurposing flop, touting post hoc data
Around 20 million more doses of the US-authorized Covid-19 vaccines will be shipped overseas in June, President Joe Biden said Monday.
The donation comes as Biden promises a new effort to increase supply around the world. It’s the first time he’s pledged to give away doses that could be used in the US, The New York Times reports.
As the number of cases and Covid-19 related deaths has plummeted in the US, they have skyrocketed abroad, particularly in India. The 20 million doses are from Pfizer-BioNTech and J&J. In April, Biden pledged 60 million doses of AstraZeneca’s vaccine, though they are not approved for use in the US, and can’t be used until ruled safe by regulators.
Advocates have called for countries with a declining number of cases to donated to Covax and increase manufacturing plans in closer proximity to countries that need help the most. — Josh Sullivan
After its repurposed treatment flopped in PhII, BerGenBio rolls out new data from post-hoc analysis
About a month after admitting that its repurposed AXL inhibitor failed the primary endpoint in a Phase II Covid-19 study, BerGenBio says it has new data showing the drug can increase the rate of ventilator-free survival in more severe patients. But there are still some questions left unanswered.
For one, BerGenBio didn’t release any p-values along with the new results. And the data are from a post-hoc analysis, which can be a tough sell at the FDA.
The Phase II trial, dubbed BGBC020, enrolled a total of 115 hospitalized Covid-19 patients in South Africa and India. But this analysis was conducted in a subgroup of patients (more than half of the original trial population) who had higher baseline severity, and C-Reactive Protein (CRP) levels of greater than 30mg/L. CRP is a biomarker used to detect acute inflammation, and in Covid-19 patients, rising CRP levels in the bloodstream indicate increasing disease severity.
BerGenBio said 90% of patients treated with its AXL inhibitor bemcentinib survived to Day 29 without being admitted to the ICU or needing a ventilator, compared to just 72% of patients given standard of care alone. The candidate was well-tolerated, the Norwegian company said, with no concerning safety signals noted.
However, the primary endpoint — time to improvement by two WHO grades from baseline, to time to discharge — didn’t reach statistical significance.
To evaluate overall survival, BerGenBio combined the results with the Phase II ACCORD2 study, which was conducted in the UK with a similar design. Combined survival to Day 29 was 96.5% (83 of 86 evaluable patients) in the bemcentinib arm versus 91.0% (81 of 89 patients) in the standard of care arm.
“We will continue our discussion of these results with the regulators, industry and Government partners to determine next steps,” CEO Richard Godfrey said in a statement.
Bemcentinib is also being tested alone and in combination with other therapies in solid and hematological tumors. — Nicole DeFeudis
EMA updates shelf life of Pfizer’s vaccine
As drugmakers and governments are making an effort to get Covid-19 vaccines to more remote areas, the European Medicines Committee has recommended changing the approved storage period of Pfizer’s jab from five days to a month, the committee announced Monday.
The vaccine still must be stored between the temperatures of 2 and 8 degrees Celsius. The change will help the rollout of vaccines in EU countries, the EMA said. It will also help reduce the number of vaccines that are forced to be thrown out. Previously, local vaccination sites were often forced to dispose of the jabs if they were left thawed for too long.
At the end of April, Moderna announced that its own mRNA vaccine now has a 3-month refrigerated shelf life, up from the 1 month previously approved. Catalent, a CDMO that is responsible for the manufacturing of millions of doses, entered a partnership with Sterling to provide ultra-low temperature freezers for the preservation of doses en route to remote areas that often lack adequate refrigeration or electricity. — Josh Sullivan
Vaccine from Medicago and GSK produces positive PhII results
A Covid-19 vaccine made in collaboration between Medicago and GlaxoSmithKline reported positive Phase II trial data Tuesday.
Nearly 10 times the amount of antibodies were found in patients dosed with the vaccine than a panel of patients recovering from the virus, the companies announced in a release. There were no severe side effects reported, and the side effects reported were short and mild.
Phase III launched on March 16. Trial sites are enrolling patients in Canada, the US, the UK and Brazil. Each site enrolled up to 306 patients. The candidates has been granted fast track designation by the FDA in the US, and Health Canada has initiated a review under interim order.
The plant-derived vaccine is made up of virus-like particles, that produce non-infectious versions of the virus. The VLPs mimic the native structure of viruses, which helps them be recognized by the immune system, Medicago says on its website.
The company first produced a VLP 20 days after obtaining the virus. — Josh Sullivan
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