Covid-19 roundup: Regeneron asks FDA: Which government agencies are tracking variants of concern?; Pfizer, AstraZeneca vaccines mostly hold strong against Delta variant
As the race to keep Covid-19 variants at bay continues, Regeneron is calling on the FDA to provide additional clarity on which government agencies are actually tracking and publishing lists on variants of concern like the Delta variant.
The New York-based biotech, which has made a name for itself during the pandemic for not only treating former President Trump with its antibody cocktail but also developing a cocktail that can withstand the changing nature of the coronavirus in the US. Meanwhile, its competitors from Eli Lilly were pulled from the market late last month as variants were able to penetrate the firm’s antibody drugs.
Lilly clarified that its combo of bamlanivimab and etesevimab administered together does not retain neutralization effects against the Gamma or Beta variants, has slightly reduced activity against the Epsilon, Iota and Kappa variants, but does retain neutralization activity against the Delta and Alpha variants.
“Sponsors developing monoclonal antibodies targeting emerging SARS-CoV-2 variants would benefit from knowing which Agencies are tracking and publishing lists with the variants of concerns that should be targeted, similarly to what is done with influenza virus strains,” Regeneron said in a comment posted recently by the FDA.
A Regeneron spokesperson noted to Endpoints News that the company offers a publicly-available tracking dashboard on variants, including through this dashboard we’ve made publicly available and that is refreshed daily with new genomes/metadata from GISAID, which is a global initiative and primary source that provides open-access to genomic data of influenza viruses and the coronavirus.
The biotech also suggested that FDA could strengthen its recommendations from its February guidance, and help ensure that sponsors are best positioned to develop monoclonal antibodies to the SARS-CoV-2 variants posing the greatest threats to public health.
Regeneron also suggested that the CDC and/or the WHO guidance documents on variants are referenced in FDA’s guidance. — Zachary Brennan
New study shows Pfizer/BioNTech, AstraZeneca vaccines hold up against Delta variant
A new study found “only modest differences” in protection offered by the Pfizer/BioNTech and AstraZeneca Covid-19 vaccines against the Delta variant, which has become the dominant strain in the US.
On Tuesday, CDC director Rochelle Walensky said the Delta variant, which was first identified in India, now accounts for about 83% of all Covid-19 cases in the US, up from just over 50% a few days prior. This particular strain is thought to have increased replication, which leads to higher viral loads and increased transmission.
Earlier this month, researchers at the Guangdong Provincial Center for Disease Control and Prevention reported that on average, people infected with the new strain had 1,000 times more copies of the virus in their respiratory tracts than those infected with the original strain.
According to a study funded by Public Health England and published in the New England Journal of Medicine, two doses of Pfizer’s vaccine were found to be 88% effective against the Delta variant, compared to 93.7% effective against the Alpha strain. And AstraZeneca’s shot was 67% effective against the Delta variant, versus 74.5% effective against the Alpha.
The protection offered by just one shot of either vaccine was “notably lower,” the researchers said, with both vaccines showing efficacy rates around 30.7% for the Delta variant and 48.7% for the Alpha variant.
“Only modest differences in vaccine effectiveness were noted with the delta variant as compared with the alpha variant after the receipt of two vaccine doses,” the researchers wrote.
A different study published on Monday (which has not been peer-reviewed) showed that neutralizing titers induced by J&J’s vaccine decreased 5.4-fold against the “Delta plus” variant, a mutation that scientists say allows the virus to better attack the lungs. — Nicole DeFeudis
Top Chinese official speaks out against WHO’s Covid-19 origin study — report
Amid brewing controversy over the origins of Covid-19, China’s National Health Commission Vice Minister Zeng Yixin said he was “rather taken aback” by the World Health Organization’s plans for the second phase of a study to rule out whether the virus leaked from a lab, according to the Associated Press.
Zeng reportedly dismissed the lab-leak theory as a rumor lacking in common sense.
“It is impossible for us to accept such an origin-tracing plan,” he told reporters, per the AP.
The WHO said back in February that the possibility of the novel coronavirus stemming from the result of a lab accident was “extremely unlikely,” adding that evidence continues to point to the virus jumping from animals to humans.
However, the lab accident theory, which was at times promoted by former President Donald Trump’s administration, has gained traction in the US, with the controversy erupting back in May when President Joe Biden ordered the US community and government labs to double down on their efforts to reach a consensus.
“Certainly, the people who investigated it say it likely was the emergence from an animal reservoir that then infected individuals, but it could have been something else, and we need to find that out. So, you know, that’s the reason why I said I’m perfectly in favor of any investigation that looks into the origin of the virus,” NIAID director Anthony Fauci said at a Senate Appropriations Committee hearing in May.
Chinese officials have repeatedly denied that the Wuhan Institute of Virology in China had anything to do with the outbreak, and Zeng said the Wuhan lab has no virus that can directly infect humans, according to the AP. — Nicole DeFeudis
For a look at all Endpoints News coronavirus stories, check out our special news channel.