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US in­ves­ti­gates po­ten­tial safe­ty sig­nal with Pfiz­er Covid boost­ers

The FDA and the CDC are investigating a “preliminary signal” of whether there might be an increased risk of stroke for people who got Pfizer and BioNTech’s updated Covid-19 vaccine booster.

In a statement posted on the CDC’s website, the agency said its monitoring system for vaccine side effects had been triggered to look for a potential issue with the shots in people ages 65 and older.

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

Next-gen Covid vac­cines: No more quick vari­ant up­dates and RCTs may be re­quired, CBER leader writes

Gone are the days of Covid-19 vaccine developers promising to quickly shift their mRNA vaccines to target the next variant every three to four months.

Now, CBER Director Peter Marks is calling on the Modernas and BioNTech/Pfizers of the world to really start considering to develop a “distinctly improved generation of SARS-CoV-2 vaccines offering longer protection with greater scope.”

Writing in a JAMA viewpoint yesterday, Marks and two coauthors from Brown University’s medical school made clear that:

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Stéphane Bancel, Moderna CEO (Joel Saget/AFP via Getty Images)

Up­dat­ed: Mod­er­na rounds out 2022 with $18.4B in vac­cine sales, boosts R&D bud­get for 2023

Moderna CEO Stéphane Bancel is revving the engines going into 2023, with a whopping $4.5 billion R&D budget and a new priority review voucher.

The company’s full-year sales totaled $18.4 billion, it announced on Monday, falling shy of the chief executive’s previous $21 billion projections. Bancel cited delivery delays, short-term supply shortages and a “very complex third quarter from a manufacturing standpoint” upon lowering the guidance last quarter, while promising that the company is “in a much better place” for 2023.

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Novavax CEO Stanley Erck and CureVac CEO Franz-Werner Haas (Andrew Harnik/AP Images; Christoph Schmidt/picture-alliance/dpa/AP Images)

New year, new CEOs for Covid vac­cine mak­ers Cure­Vac and No­vavax

Two biotech companies that have been on long journeys to push through Covid vaccines are getting new CEOs this year.

CureVac CEO Franz-Werner Haas is stepping aside after three years in the position for a new chief who’s coming from Sanofi. Alexander Zehnder will join CureVac as CEO of the mRNA biotech on April 1, leaving his current position as global head of oncology at Sanofi. According to a CureVac representative, “it’s currently not planned” that Haas will remain on the management board after stepping down as CEO.

Scoop: To fund Covid-19 nasal vac­cine boost­er, Yale spin­out snags Se­ries A

A biotech working to create an intranasal vaccine booster for the ongoing Covid-19 pandemic has raised a Series A, the startup’s CEO confirmed to Endpoints News.

Known as Xanadu Bio, the company was spun out of Yale University. The raise will bankroll non-human primate studies for an intranasal spike mRNA vaccine booster, CEO and founder Bruce Turner told Endpoints via email.

A Dec. 27 SEC filing outlines a $30 million round for the Gladwyne, Pennsylvania biotech. Turner declined to discuss the funding or the names of the company’s investors, but said the company has “runway until late 2024.”

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Ever­est Med­i­cines be­gins pro­duc­tion at its new $129M+ mR­NA vac­cine man­u­fac­tur­ing fa­cil­i­ty in Chi­na

The China-based biotech Everest Medicines has opened the doors to a new manufacturing facility to produce mRNA-based vaccines.

Everest’s new facility, which is located just to the west of Shanghai in Jiashan, Zhejiang Province, is around 58,000 square meters, or an estimated 624,306 square feet, and had an investment of more than RMB 900 million ($129 million). The manufacturing facility plans to produce around 700 million doses of mRNA vaccine annually.

Roche's Actem­ra wins ap­proval for hos­pi­tal­ized Covid pa­tients

Roche upgraded its emergency use authorization for Actemra in certain hospitalized Covid-19 patients to a full FDA approval, the company announced Wednesday, as cases climb in the US.

The approval comes roughly a year and a half after the monoclonal antibody treatment received an EUA to treat hospitalized patients 2 years and older who are also receiving systemic corticosteroids and require supplemental oxygen, ventilation or life support. While the approval is only for adults, Actemra will continue to be available for younger patients under the EUA.

Uğur Şahin, BioNTech CEO (Kay Nietfeld/picture-alliance/dpa/AP Images)

Up­dat­ed: BioN­Tech sends mR­NA Covid-19 vac­cines to Chi­na for 20,000 ex­pats

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.

Peter Marks, CBER director (Greg Nash/Pool via AP)

CBER's Pe­ter Marks says Covid-19 shots to mir­ror flu shots: Man­u­fac­tur­ers will be in­ter­change­able

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.”

Bill Henshaw, Axcella Health CEO

Ax­cel­la re­duces work­force by 85%, pri­or­i­tizes long Covid drug re­search

After missing its primary goal in Phase IIa trials for its long Covid drug, Axcella Health announced Wednesday that it’s cutting 85% of its workforce, has hired a bank to explore strategic alternatives, and is reshuffling its pipeline.

As part of the restructuring, CFO Bob Crane and chief people officer Virginia Dean are leaving the biotech, and the company is now exploring “a range of strategic alternatives to maximize shareholder value,” including working with an investment bank — often a sign that it will sell itself or seek last-resort financing.