About a week after Pfizer asked regulators to expand its Covid-19 booster shot EUA to include all adults, the CDC’s Advisory Committee on Immunization Practices has scheduled a meeting to discuss the idea.
ACIP will meet this Friday, and is expected to give an official recommendation soon after, The Associated Press reported on Tuesday.
Pfizer and BioNTech’s booster shot is currently authorized for those 65 years and older, or at high-risk of a Covid infection, including health care workers and others with occupational hazards. Before deciding on those limitations, the FDA’s advisory committee on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote.
Pfizer says its new submission is based on the results from a Phase III trial showing a relative vaccine efficacy of 95% for those who received a booster compared to those who did not. That study was conducted with 10,000 volunteers in the US, Brazil and South Africa when the Delta variant was the prevalent strain.
Though Moderna’s booster dose is currently limited to the same population as Pfizer’s, the FDA has authorized ‘mix-and-match’ booster doses for those who are eligible. People who received the J&J vaccine are eligible to receive a booster of any type after two months.
Some states aren’t waiting for the government to authorize booster shots for all adults. States like Arkansas, Colorado and New Mexico have opened up mRNA booster vaccine eligibility for all adults, CBS News reported recently. — Nicole DeFeudis
US buys $1B worth of GSK and Vir’s monoclonal antibody treatment
The US government has now contracted to purchase approximately $1 billion worth of GlaxoSmithKline and Vir’s monoclonal antibody treatment for early Covid-19, the companies said Wednesday.
The latest government contract is worth $651.1 million and covers around 300,000 doses, according to the Wall Street Journal.
The government has now distributed more than 175,000 doses nationwide, and GSK/Vir say including the contracts announced today, GSK and Vir have received binding agreements for the sale of more than 750,000 doses of sotrovimab worldwide. Distribution of the treatment, known as sotrovimab, was recently handed over to the US government too. — Zachary Brennan
For years, paper-based processes and individual point solutions dominated the clinical research landscape, and patient participation in clinical trials was largely an in-person engagement. But when the COVID-19 pandemic took a stronghold, traditional clinical trial methods emerged as inadequate, putting clinical trials and the life sciences industry at a crossroads. Practically overnight, the industry had to rapidly shift to decentralized clinical trial methods, while maintaining data quality and regulatory compliance.
Al Sandrock (Biogen via Youtube)
Two years after Al Sandrock jumped from CMO to the top post in R&D — and just months after the hyper-controversial approval of the experimental Alzheimer’s drug aducanumab (Aduhelm) — Sandrock is planning to step out of his long career at Biogen.
Late Monday evening the big biotech put out word that Sandrock, a longtime fixture in the company after a 23-year stint, is hitting the exit.
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Albert Bourla, Pfizer CEO (AP Images)
If you thought Pfizer was raking it in with megablockbuster sales of its BioNTech-partnered Covid-19 vaccine — last projected at $36 billion for 2021 — think again.
As the pharma giant sends off its EUA submission for its antiviral pill to the FDA, the Washington Post, New York Times and others are reporting that the US government is planning a $5 billion contract to purchase 10 million courses of the treatment, dubbed Paxlovid.
Following an oral explanation held at the November meeting of the EMA’s human medicines committee, Biogen received ‘a negative trend vote’ on its marketing application for its controversial Alzheimer’s drug aducanumab, the company said Wednesday morning.
The setback is just the latest in a string of negatives — from an anemic launch to rejection of coverage from the VA — since the surprising June approval of the drug by the FDA that led to multiple resignations from an advisory committee that unanimously rejected it.
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A month after conceding a mid-stage failure, Roche is dropping the Covid-19 antiviral pill it was jointly developing with Atea.
The little biotech, which had received $350 million cash upfront from Roche last October and raised another $215 million earlier in the pandemic, said it has both the financial resources and talent to carry on with a planned Phase III trial and eventually steer the drug, AT527, to market. Roche had originally bought in to grab the ex-US rights.
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A few weeks after Jennifer Doudna introduced CRISPR/Cas9 genome editing to the world, one of her old students decided to take the central part of the biology-altering invention and kill it.
CRISPR/Cas9, as the name implies, is a two-part system: a string of letters called a guide RNA, that says where to cut the DNA. And an enzyme, Cas9, that does the cutting. Often compared to molecular scissors, it was the first system that allowed researchers to cut DNA with ease and precision, promising potential cures for genetic diseases such as sickle cell and cystic fibrosis.
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Catherine Stehman-Breen and Vic Meyer, Chroma CEO and CSO
A handful of the world’s most prominent gene editing-focused academics have been working for over a year on a new company built around a new approach for modifying DNA to treat disease. Known as Chroma Medicine, it launched on Wednesday with $125 million in early funding from Atlas, Newpath, Cormorant and several other VCs.
Chroma will focus on a markedly different way of modifying the genome than most of the gene editing biotechs that have arisen since CRISPR was pioneered nearly a decade ago. Instead of trying to erase or rewrite portions of a patient’s actual DNA — those As, Ts, Cs and Gs — Chroma will try to change the way that DNA is expressed in the cell.
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Following a similar deal forged by Merck for its Covid-19 drug molnupiravir, Pfizer on Tuesday agreed to allow the UN-backed Medicines Patent Pool to license the company’s potential treatment Paxlovid to make it more readily available in 95 low- and middle-income countries.
The agreement allows MPP to grant sub-licenses to qualified generic drug manufacturers to facilitate additional production and distribution of the investigational antiviral, which has yet to be authorized.
David Berry, Valo Health CEO (Flagship Pioneering)
By most accounts, the biotech sector has boomed throughout the Covid-19 pandemic, particularly for companies looking to go public through a traditional IPO or the ever-more-popular SPAC route. But as one Flagship biotech found out, some of the luster might be wearing off.
Valo Health and its SPAC partner, the first of Khosla Ventures’ three blank check companies, called off their merger late Monday in a statement citing only the vague ‘current market conditions’ as the reason. The termination came just one day before a shareholder meeting where a vote on the merger was expected.
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