Coronavirus channel feed

Ex­clu­sive in­ter­view: Pe­ter Marks on why full Covid-19 vac­cine ap­provals could be just months away

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, took time out of his busy schedule last Friday to discuss with Endpoints News all things related to his work regulating vaccines and the pandemic.

Marks, who quietly coined the name “Operation Warp Speed” before deciding to stick with his work regulating vaccines at the FDA rather than join the Trump-era program, has been the face of vaccine regulation for the FDA throughout the pandemic, and is usually spotted in Zoom meetings seated in front of his wife’s paintings.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Covid-19 roundup: No­vavax shakes up lead­er­ship with two pro­mo­tions and de­par­ture of CFO; Mod­er­na, No­vavax shots added to mix-and-match study in the UK

Novavax has had a busy month, filled with supply chain issues and manufacturing deals that have affected the rollout of its Covid-19 vaccine. Tuesday, the company announced updates to its leadership team.

CFO Greg Covino will step down from that role after just five months for personal reasons, the release said, but take on a new role as executive advisor. John Trizzino, current chief commercial officer and chief business officer, will take the CFO role over in the interim.

Stéphane Bancel, Moderna CEO (Adam Glanzman/Bloomberg via Getty Images)

UP­DAT­ED: Mod­er­na says Covid-19 boost­ers stand a fight­ing chance against new vari­ants

A day before its second annual Vaccines Day, Moderna has posted an update on its crown jewel, including a 6-month look at the Covid-19 shot and new preclinical data that suggest its booster candidates stand a fighting chance against new variants.

Moderna’s variant-specific booster mRNA-1273.351, which was designed to target the B.1.351 mutation first identified in South Africa, “closed the neutralizing titer gap for variants of concern” in mice, the company said on Tuesday afternoon. When given at the 6-month mark, the booster elicited neutralizing titers against the variant that were comparable to those produced against the original virus.

Covid-19 roundup: Cit­ing a lack of need, Gilead cuts remde­sivir study; No­vavax vac­cine pro­duc­tion slowed due to sup­ply short­ages

Gilead is halting its remdesivir study in high-risk, non-hospitalized Covid-19 patients after a decision that the study no longer addresses an unmet need, a statement said.

The study’s stoppage is not due to efficacy or safety concerns, the company stated.

“While COVID-19 continues to impact many patients and their loved ones, unmet medical needs have evolved over the course of the pandemic. The primary unmet need for non-hospitalized patients with COVID-19 is for effective and convenient therapies that can be easily administered at home. Gilead remains committed to developing treatment options for non-hospitalized patients with COVID-19 that address this need,” a statement says.

UP­DAT­ED: J&J paus­es vac­cine roll­out as feds probe rare cas­es of blood clots

The FDA and CDC have jointly decided to stop administering J&J’s Covid-19 vaccine after reviewing data involving six reported US cases of a rare and severe type of blood clot in individuals after receiving the vaccine.

CDC will convene a meeting of its Advisory Committee on Immunization Practices on Wednesday to further review these cases and assess their potential significance. “FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research and Anne Schuchat, Principal Deputy Director of the CDC, said in a joint statement Tuesday morning.

Covid-19 roundup: As­traZeneca's Farx­i­ga fails PhI­II test; Sup­ply deal for Eli Lil­ly's so­lo bam­lanivimab of­fi­cial­ly can­celed

Around the same time AstraZeneca struck up a vaccine partnership with Oxford last April, the pharma giant also put together a game plan to develop treatments — both new and repurposed — for Covid-19. One of them has now ended in failure.

The Phase III DARE-19 trial recruited 1,250 patients hospitalized with Covid-19 over the past year and gave half of them the diabetes drug Farxiga on top of standard of care therapy.

IPO mar­ket con­tin­ues to churn with a pair of Covid-19 biotechs seek­ing Nas­daq, while mi­to­chon­dria-fo­cused Re­neo de­buts

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

Biotech continues to see a huge flow of companies looking to make their public debuts as the second quarter gets underway.

Two European biotechs working on Covid-19 vaccines, Vaccitech and Valneva, both filed their SEC paperwork over the weekend, while mitochondrial disease company Reneo Pharmaceuticals priced its own IPO last Friday. Per Endpoints News’ tally, the IPO count this year has now surpassed 40 biotechs that have priced or filed, roughly on pace to match 2020’s record of 92.

Re­gen­eron’s Covid mAb as a pro­phy­lac­tic in­jec­tion: Re­duced risk of symp­to­matic in­fec­tion by 81%

Regeneron’s monoclonal antibody cocktail for Covid-19 continues to impress, this time in a joint trial with NIH that found the normally infused treatment works as a preventive subcutaneous injection.

The trial showed that REGEN-COV (casirivimab with imdevimab) reduced the risk of symptomatic infections by 81% in those who did not have Covid before the trial within 29 days. There were 11 cases in the 753-person mAb arm, versus 59 cases in the 752-person placebo arm.

Joe Biden (Credit: Doug Mills/The New York Times/Bloomberg via Getty Images)

Biden’s bud­get wish list: Re­store the CDC, build a new NIH re­search cen­ter, pump in bil­lions to end the opi­oid and HIV epi­demics

President Joe Biden’s first budget request (Congress is the ultimate decider on budgets) for FY 2022 includes a massive influx of funds to the CDC, plans to launch a new $6.5 billion research center within the NIH, as well as almost $11 billion to end the opioid epidemic and another $670 million to aggressively reduce new HIV cases.

But details on what exactly this new $6.5 billion, DARPA-like, NIH-based center, to be known as Advanced Research Projects Agency for Health (ARPA-H), will research remain to be seen. Biden’s budget request only said the center will initially focus on a wide range of diseases that other NIH centers typically work on.

Emer Cooke, Shutterstock

UP­DAT­ED: EMA in­ves­ti­gat­ing 4 'se­ri­ous cas­es' of blood clots fol­low­ing J&J vac­ci­na­tions

The European Medicines Agency’s safety committee said last Friday that it has initiated a review of 4 “serious cases of unusual blood clots with low blood platelets,” including one death, reported after people received the J&J vaccine in the US.

The agency offered an update on Wednesday that it is expediting this evaluation and currently expects to issue a recommendation next week. “While its review is ongoing, EMA remains of the view that the benefits of the vaccine in preventing COVID-19 outweigh the risks of side effects,” the agency said in a statement. J&J announced on Tuesday that it would pause the distribution of its vaccine across Europe until the investigations are complete.