On Jan. 26, the FDA’s vaccines adcomm will meet to discuss the future of Covid-19 booster shots and variant strain selection moving forward, and CBER Director Peter Marks yesterday previewed some of what will be discussed in that meeting.
As the bivalent booster uptake has stalled, particularly among children, Marks is now pointing to ways to simplify the process.
The VRBPAC adcomm won’t only look at what the composition of these Covid-19 vaccines should be, and what’s the timing for selecting new strains, but also how often strain selection should take place, he said, noting that the FDA is “trying to get to some sense of normalcy for how we treat vaccinations.”
While noting the varied vial sizes and types of vaccinations for different age groups from Pfizer and Moderna, which creates challenges for keeping things straight for pharmacists, he pledged to simplify the process so that it more closely mirrors the influenza shot model, with caveats around the differences between Covid-19 and the flu.
Marks, speaking in conversation with Dana DeShon, chair of the professional association for pediatric nurse practitioners’ immunization special interest group, as part of the Covid-19 Vaccine Education and Equity Project, answered a question on whether a child under 4 years old who completed the Moderna primary series could receive a Pfizer booster:
“The issue would be that for these vaccines, unless they’ve moved into a new age range, we recommend the under 4s stick with the same brand,” Marks said.
But he added that this question circles back to the reason for holding this adcomm, noting:
This is one of the issues that needs some simplification because ultimately we’d like things to be as simple as they are with influenza vaccines where it doesn’t matter what manufacturer’s vaccine you’ve received. It would be nice to essentially swap out. That will be considered at that time, and hopefully within a couple of months there will be better guidance in that regard.
Pfizer and Moderna did not immediately respond to questions on making their shots the same.
The CDC also notes on its website that while all flu vaccines will protect against the same 4 flu viruses, different flu vaccines are manufactured differently, and different preparations have different indications licensed by the FDA, such as for a specific age range. In addition, LAIV (the nasal spray flu vaccine) is not recommended for use in some populations, the CDC says.
The differences between the Moderna and Pfizer Covid-19 vaccines came to a head with the recent booster authorizations.
For Pfizer and BioNTech’s Covid vaccine, the FDA recently authorized a new bivalent third dose for children 6 months through 4 years of age who have not yet received the third dose of the three-dose primary series with the monovalent version. But the monovalent version of Pfizer-BioNTech’s vaccine remains authorized for administration as the first two doses of the three-dose primary series in individuals 6 months through 4 years of age, and as a two-dose primary series for individuals 5 years of age and older, and as a third primary series dose for individuals 5 years of age and older who are immunocompromised.
For Moderna, its bivalent booster, just as it is for those 6 years and older, is now authorized for children 6 months through 5 years of age at least 2 months after completion of primary vaccination with the monovalent Moderna vaccine.
Similar to Pfizer, Moderna’s monovalent version is also authorized as a two-dose primary series in individuals 6 months and older and as a third in the primary series dose for individuals 6 months of age and older who are immunocompromised.
The Asia Pacific region, which has more than 6,772 trial sites each with access to an average of 2,136 million people, has considerable underutilized capacity presenting an opportunity for growth in multinational trials in the region.
Demand for Asia Pacific trial sites is strong with almost half of the more than 27,000 clinical trials initiated in 2021 having in Asia Pacific, according to the latest analysis from GlobalData in a new report titled State of the Global Biotech Landscape: Where the Opportunities Lie.
While Alex Harding is a practicing physician, he’s long envisioned a career on the business side of drug development. Next year, he’s seizing an opportunity to further those goals at CRISPR Therapeutics.
The Swiss-American company announced on Monday that Harding — one of Endpoints News’ 20 under 40 honorees in 2020 — is joining on Jan. 5 as SVP and head of business development. CEO Samarth Kulkarni said in a news release that the appointment will be “critical in driving the next phase of growth for CRISPR.”
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Pfizer has found a Phase II candidate that it believes would pair well with its experimental BCMA drug, and it’s infusing $25 million into the biotech behind the therapy.
As part of a new clinical development collaboration, Pfizer will test elranatamab, a BCMA CD3-targeted bispecific, in combination with ORIC Pharmaceuticals’ ORIC-533, a small molecule inhibitor of CD73.
ORIC is selling shares to Pfizer at a premium, but the price of $4.65 per share is still less than half of where it started the year. Co-founded by inventors of Xtandi and Erleada, the South San Francisco biotech’s stated mission is to tackle resistance to cancer drugs. But its initial lead program flunked early studies in prostate cancer, tanking shares and leading to its termination.
One of the pioneers of first-gen CAR T has now swooped in to buy a second-gen cell therapy player with some stellar scientific ties, impressive early responses and a clinical record that includes a high-profile blowup in the clinic that killed several patients.
Gilead sub Kite is putting out word today that it’s nailed down the buyout of Tmunity, a cell therapy spinout out of Penn that was derailed by lethal toxicity.
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Enveda Biosciences will enter the clinic next year with at least one of its three main programs thanks to a $68 million boost in financing — about $55 million via equity and the remainder debt.
Founded by an early employee at AI startup Recursion Pharmaceuticals, Enveda has adjusted its priorities since disclosing a $51 million Series A in June 2021. At the time, CEO Viswa Colluru told Endpoints News the three core areas were Wilson disease, NASH and Parkinson’s.
Two biotech leaders are facing the possibility of decades in prison after a federal grand jury in Maryland indicted them on multiple charges related to a scheme to defraud investors about the potential of the drug leronlimab, a monoclonal antibody investigational drug also known as PRO 140.
CytoDyn’s former CEO Nader Pourhassan drew attention over the last two years for loudly touting leronlimab as an effective treatment for HIV, cancer and Covid-19, despite clinical data that indicated the opposite.
Adderall has been getting harder to obtain and manufacture — and now a Congresswoman wants answers from the FDA and the DEA.
Rep. Abigail Spanberger (D-VA), re-elected to her third term in Congress last month, is asking that the agencies address questions related to production quotas and to remedy an ongoing shortage of Adderall to patients who rely on it, according to a letter to FDA Commissioner Robert Califf and the DEA’s active administrator Anne Milgram on Tuesday.
China has opened up its doors to a foreign Covid-19 vaccine for the first time, though not for its own citizens, a German government spokesperson told Reuters on Wednesday.
BioNTech’s mRNA vaccines have been sent to China to meet the goal of vaccinating 20,000 German expatriates there, a spokesperson for the German embassy in Washington confirmed to Endpoints News. There will be additional shipments, the spokesperson said, without providing details on when or how many doses would be delivered. The shots will be provided free to Germans over 12 years old and will be shipped to German embassies and companies across the country.
Moderna has plucked a new commercial executive from the ranks at Merck as CEO Stéphane Bancel promises the company is in a “much better place” for 2023 Covid-19 vaccine deliveries.
Chantal Friebertshäuser is joining Moderna on Jan. 1 as senior vice president of commercial, where she’ll be responsible for efforts in Europe, the Middle East and Canada. Chief commercial officer Arpa Garay — who also spent years at Merck — touted a slate of vaccine contracts lined up for 2023 on Moderna’s recent Q3 call, including in Switzerland, Kuwait and Canada, with more to come.
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