Covid-19 roundup: Pfizer, BioNTech set new production quota for vaccine at 2B doses in 2021; New data show IL-6 inhibitor could be effective treatment after all
Pfizer and BioNTech are well on their way to a global rollout of their mRNA-based Covid-19 vaccine, BTN162b2. Even with logistical challenges hampering that plan, Germany’s BioNTech is planning a vast expansion of its production capacity in the coming year.
BioNTech plans to churn out more than 2 billion doses of BNT162b2 in 2021, far outpacing the 1 billion doses tied up in supply commitment around the globe, the company said in a virtual presentation at the virtual JP Morgan Healthcare Conference.
BioNTech tied to the re-upped goals to “continues process improvement and expansion” at its sites in Germany and three Pfizer plants in the US. Churning out that many doses, however, will be contingent on Pfizer and BioNTech’s ability to keep icing more supply agreements to make that commitment worthwhile, the company said.
The rollout of Covid-19 vaccines in the US has been much slower than expected with a vaccuum of leadership at the federal level and a hodge-podge vaccination drive at the state level.
New data add new life to Actemra’s chances
BARDA said they would stop funding IL-6 blockers for Covid-19 back in August. But on Jan 7, new results from REMAP-CAP showed Roche’s IL-6 inhibitor Actemra may be worth another look.
In a study by the global adaptive trial network, patients given the rheumatoid arthritis drug (chemically known as tocilizumab) and sarilumab within 24 hours of entering intensive care saw a 24% reduction in relative risk of death, according to the UK’s National Institute for Health Research. The treatment also has the potential to shorten intensive care stays by 10 days, the agency said.
The study included 3,900 Covid-19 patients across 15 European countries and was led by Imperial College London, the Intensive Care National Audit & Research Centre (ICNARC) in the UK, and Utrecht University. As of November, 75% of participants had been recruited in the UK through the NIHR’s Clinical Research Network. The results have yet to be peer-reviewed, but researchers are working to analyze and publish them “as soon as possible,” the NIHR announced.
The findings build on results released in November, in which a data safety and monitoring board reviewed data from 303 patients and determined Actemra had a 99.75% chance of being better for the sickest Covid-19 patients than giving them no immune modulator at all. However, the degree to which Actemra helped patients remained unclear.
“This is a significant step forward for increasing survival of patients in intensive care with COVID-19,” deputy chief medical officer Jonathan Van-Tam said in a statement. “The data shows that tocilizumab, and likely sarilumab, speed up and improve the odds of recovery in intensive care, which is crucial for helping to relieve pressure on intensive care and hospitals and saving lives.”
The news comes as the UK’s cumulative Covid-19 cases top 3 million, with 59,937 new cases in the last 24 hours. A new variant of the virus was detected in the UK weeks ago, which scientists believe may spread more easily. Pfizer and Moderna have both said they believe their Covid-19 vaccines will protect against the variant, and are conducting tests to confirm. Days ago, Pfizer said its jab appeared to be effective against the strain in a study conducted with the University of Texas Medical Branch.
Scott Gottlieb criticizes US vaccine rollout
As the US struggles to get vaccines in arms, former FDA director Scott Gottlieb says the country needs a reset.
“We need to hit the reset and adopt a new strategy in trying to get out to patients,” he told CBS’ “Face the Nation” on Sunday.
According to the CDC, 22.1 million doses have been distributed, and 6.68 million Americans have received their first dose. That’s a far cry from the country’s initial hopes. In December, OWS chief Moncef Slaoui said the plan was to distribute 40 million doses by the end of December, and vaccinate 100 million people by the end of March.
“Right now, there’s 40 million doses sitting on a shelf somewhere. So the feds say it’s with the states. The states say it’s with the feds. It really doesn’t matter to the patient who’s not getting access to to the injection,” Gottlieb told CBS.
To pick up the pace, President-elect Joe Biden has announced plans to release nearly all available doses, rather than reserve half of the supply for second doses as the Trump administration has been doing.
Slaoui has pushed the FDA to consider halving Moderna’s vaccine to counteract the distribution lags, but the agency poured cold water on the idea last week. Changing authorized vaccine doses or schedules for any Covid-19 vaccine would be “premature” and is not supported by available data, FDA chief Stephen Hahn and CBER director Peter Marks said in a joint statement.
“We cannot conclude anything definitive about the depth or duration of protection after a single dose of vaccine from the single dose percentages reported by the companies,” the statement read.
A correction has been made to clarify that REMAP-CAP is not sponsored by BARDA.
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