Covid-19 roundup: Oxford Biomedica and AstraZeneca extend vaccine deal; FDA wants boosters for newer variants
An Oxford University spinout and one of the major players in the pharma industry are extending their collaboration on its Covid shot.
Oxford Biomedica and AstraZeneca on Friday announced that they have signed a new three-year agreement on future manufacturing for the AstraZeneca Covid-19 vaccine. According to Oxford Biomedica, this deal is an expansion of the original agreement announced between the two companies during the first waves of the pandemic in September 2020.
Under the extension, the manufacturing of vaccines at Oxford Biomedica’s 84,000-square-foot facility, called Oxbox, will be available to AstraZeneca on an as-needed basis beyond this year. The manufacturing of Covid-19 vaccines at Oxbox is expected to be completed in the last quarter of 2022, as part of the original commitment.
For the batches that were already manufactured in the first half of 2022, it plans to have revenue of £30 million ($36.1 million) Oxford Biomedica.
“While contributing to the efforts to fight the pandemic, this has also demonstrated Oxford Biomedica’s ability to expand the scope of our innovative process development services and deliver high-performing manufacturing solutions beyond lentiviral vectors,” said Roch Doliveux CEO of Oxford Biomedica in a statement.
The original deal in 2020 was a five-year agreement to help manufacture the Covid-19 vaccine being developed by Oxford University’s Jenner Institute and AstraZeneca. The adenoviral vector vaccine uses a weakened version of a common cold-causing virus to deliver the gene for a coronavirus into human cells.
FDA updates its recommendations for booster doses, asking for protections against BA.4 and BA.5
The FDA is recommending that Covid-19 booster shots should be updated to protect against not just the original Omicron variant, but its more virulent strains.
VRBPAC voted in favor of including an Omicron component in Covid-19 vaccines that would be used for booster doses in the US beginning in fall 2022, advising manufacturers to update their shots to add a BA.4/5 spike protein to create bivalent booster vaccines.
Outside experts that are on FDA’s adcomm initially met on Tuesday to discuss whether a change to the current composition of Covid-19 boosters is necessary for the fall and winter. While the vaccines that have been approved and authorized for emergency use have made a difference to public health and have saved lives, the virus has evolved significantly, with recent surges around attributed to variants such as Omicron.
According to Peter Marks, director of the CBER, results from post-authorization observational studies have shown that the effectiveness of primary vaccination wanes over time against certain variants, including Omicron. And while initial booster doses have helped restore protection against severe disease and hospitalization associated with Omicron, studies have also indicated waning effectiveness of first booster doses.
The FDA expects this coming year to be a transitional period when the modified booster vaccine may be introduced, but the agency has not advised manufacturers to change the vaccine for primary vaccination, since an initial two-dose series with the FDA-authorized and approved vaccines provides a base layer of protection.
Global regulators, under the umbrella of ICMRA, also agreed earlier this week to adapt vaccines to tackle the omicron and its several variants.
Zyesami’s EUA for Covid-19 patents is rejected
The FDA on Friday rejected the EUA for Zyesami’s use for patients with critical stages of Covid-19 and who are at risk for immediate death from respiratory failure.
According to a release from NRx Pharmaceuticals, Zyesami, also known as aviptadil, was being investigated for use in a sub-group of patients that in addition to using the drug also, received Remdesivir and continued to progress. NRx Pharmaceuticals had submitted this last EUA application using data from a post-hoc subgroup analysis.
“As previously communicated, since the futility news of the ACTIV-3b / TESICO Study with ZYESAMI®, our team has already been highly focused on the development of NRX-101 for bipolar depression in patients with Acute and Sub-Acute Suicidality. Though disappointing, this decision by the FDA is not unexpected, given that they had already recently declined Breakthrough Therapy Designation for Zyesami. We will evaluate the options for Zyesami in Covid-19 respiratory failure and other lung disorders once we receive the full data set from the NIH,” said Robert Besthof, NRx’s interim CEO.
This is not the first time Zyesami has been looked at unfavorably by the government. In late May, there were more deaths in the treatment group than in the placebo cohort in an NIH study of Zyesami which was already rejected, and the data safety board recommended stopping the trial. In the treatment arm, the mortality was 37% compared to 36% in the placebo group.
This weight has brought down NRx’s stock price $NRXP through the floor, as it has dropped 87% since the beginning of the year.