Coronavirus channel feed

Pascal Soriot, AstraZeneca CEO (Chris Ratcliffe/Bloomberg via Getty Images)

Did Eu­rope blun­der in its Covid vac­cine picks? Pas­cal So­ri­ot points to a po­ten­tial mis­take — and jabs back over de­lays

While Europe is in the midst of a massive fourth Covid-19 surge, the UK has largely avoided the high levels of hospitalizations and deaths seen on the rest of the continent. And AstraZeneca CEO Pascal Soriot suggested Tuesday the reason for Britain’s better fortunes could be his company’s vaccine.

In a one-on-one interview with BBC Radio 4, a reporter asked Soriot whether he was disappointed over the UK’s decision not to use the AstraZeneca/Oxford shot as a booster. Soriot responded by touting the vaccine’s T cell response, saying some data have shown it may be more durable than mRNA shots in older people, where the focus had largely been on antibodies.

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Ugur Sahin (L) and Özlem Türeci (Bernd von Jutrczenka/picture-alliance/dpa/AP Images)

New Pfiz­er/BioN­Tech Covid vac­cine da­ta in teens show strong pro­tec­tion, lin­ing up sBLA fil­ing

Pfizer and BioNTech are planning to file for full approval of their Covid-19 vaccine for all of those over the age of 12 after they said longer-term analysis of the vaccine in teens continued to show strong protection against symptomatic cases of Covid-19 more than four months after the second dose.

With no serious safety concerns at least 6 months after the second dose for those ages 12 through 15, the companies said the data will form the basis for a planned upgrade from EUA to supplemental Biologics License Application (sBLA).

Covid-19 roundup: Ahead of FDA, EU signs off on Mer­ck­'s an­tivi­ral; Dis­tri­b­u­tion of mAbs in US see first uptick in 7 weeks

The European Medicines Agency on Friday said that Merck’s antiviral molnupiravir can now be used to treat adults with Covid-19 who do not require supplemental oxygen and who are at increased risk of developing severe disease.

The pill, known commercially in Europe as Lagevrio, has not yet been authorized in the US and has to be taken twice a day for 5 days. The EMA said it should be administered as soon as possible after diagnosis of Covid, and within 5 days of the start of symptoms. The quick authorization is based on data showing the drug reduced the chance that a newly diagnosed Covid-19 patient would be hospitalized or die by 50%, according to data presented by the company in October.

Peter Marks (Jim Lo Scalzo/Pool via AP Images)

FDA au­tho­rizes mR­NA boost­ers from Pfiz­er, Mod­er­na for all adults 6 months af­ter vac­ci­na­tion

All US adults who received two doses of an mRNA Covid-19 vaccine are now eligible for a booster shot, the FDA announced Friday.

The moves will amend the existing EUAs for the Pfizer/BioNTech and Moderna boosters, which had previously been limited to immunocompromised individuals, those older than 65 and adults at high risk for severe disease through certain comorbidities or occupational exposure. For Moderna in particular, the booster shots come in a half-dose of the original vaccine series — 50 µg instead of 100 µg — while Pfizer’s remains at 30 µg for each shot.

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President Joe Biden listens as Pfizer CEO Albert Bourla speaks (Patrick Semansky/AP Images)

Covid-19 roundup: Pfiz­er lands mas­sive $5B+ deal with US for po­ten­tial pill; Boost­ers for all adults are in­com­ing

Pfizer’s pill to treat Covid-19 is outpacing its top rival from Merck not only in terms of efficacy data but now in the size of its US government contract, too.

The US on Thursday announced it will pay $5.29 billion for 10 million courses of Pfizer’s potential treatment, which is the largest single procurement of any therapeutic or vaccine since the pandemic began. And at $529 per course for the Pfizer pill, that’s significantly cheaper than the $2.2 billion the US paid for just 3 million courses of Merck’s treatment, which adds up to about $730 per course.

Mene Pangalos (AstraZeneca via YouTube)

Pas­sive vac­ci­na­tion? As­traZeneca spot­lights six-month pro­tec­tion with Covid-19 an­ti­body among vul­ner­a­ble group

New follow-up data suggest that AstraZeneca’s long-acting antibody can protect high-risk populations from contracting Covid-19 for as long as six months, beefing up the case for it as a form of “passive immunization” or “passive vaccination.”

At a six-month cutoff for the Phase III PROVENT trial, investigators tracked an 83% reduction in risk of symptomatic Covid-19 after one dose of the antibody among 4,991 volunteers. The company did not spell out case counts on either arm, noting only that there were no severe disease or Covid-related deaths in the AZD7442 arm and two additional cases of severe Covid-19 in the placebo arm (for a total of five severe cases and two related deaths).

Covid-19 roundup: CDC ad­vi­so­ry com­mit­tee to dis­cuss Pfiz­er/BioN­Tech boost­ers for all adults; US buys up $1B in GSK/Vir mAbs

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.

Albert Bourla, Pfizer CEO (AP Images)

Covid-19 pill could add an­oth­er $15-25B to Pfiz­er's al­ready tor­rid pan­dem­ic cash flow — an­a­lyst

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.

In wake of PhII flop, Roche walks away from $350M Covid-19 an­tivi­ral pact

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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Patrick Amstutz, Molecular Partners CEO

An­oth­er one bites the dust: No­var­tis, Mol­e­c­u­lar Part­ners and their an­tivi­ral get the boot from NIH Covid study

Molecular Partners CEO Patrick Amstutz knew going into the NIH’s ACTIV-3 study that the bar for ensovibep was “very high.” A slew of Covid-19 antibodies had already flunked out of the trial — and though their Novartis-backed antibody alternative was different, he expressed cautious hope.

On Tuesday, however, he revealed that ensovibep didn’t clear that bar.

Ensovibep’s ACTIV-3 days are over after failing a futility analysis in hospitalized Covid-19 patients, the company announced. The molecule comes from a class of drugs developed by Molecular Partners that aims to perform the same functions as antibodies with far more target specificity and antiviral protection.

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