Latest Updates on the Coronavirus Disease

Pfizer, Moderna And Novavax Gear Up For Fall Covid Vaccine Rollout With An Important Head Start

A pharmacist prepares to administer Covid-19 vaccine booster shots during an event hosted by the Chicago Department of Public Health at the Southwest Senior Center in Chicago, Illinois, Sept. 9, 2022.

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The U.S. Food and Drug Administration's Covid strain selection for the next round of shots puts Pfizer, Moderna and Novavax on track to deliver new jabs in time for the fall — a decisive win for the vaccine makers as they gear up to compete against one another. 

The FDA on Friday advised the three companies to manufacture single-strain jabs targeting the omicron subvariant XBB.1.5, one of the most immune-evasive Covid variants to date. 

That strain accounted for nearly 40% of all Covid cases in the U.S. In early June, but that proportion is slowly declining, according to data from the Centers for Disease Control and Prevention. 

But facing pressure to deliver new shots by the fall, Pfizer, Moderna and Novavax began development on versions of their vaccines targeting XBB.1.5 months before the FDA's decision. Preliminary data those companies presented last week indicates that their jabs produce strong immune responses against all XBB variants. 

The FDA's strain selection means the companies won't have to scramble to manufacture shots targeting an entirely different strain, which would delay the timing of delivery. 

Pfizer said Thursday it will be able to deliver a shot targeting XBB.1.5 by July. Moderna and Novavax did not provide specific timelines for their versions.

Still, the FDA's decision means that all three companies will likely deliver their updated jabs on time.

Shots targeting XBB.1.5 seem "the most feasible to get across the finish line early without resulting in delays in availability," Dr. Melinda Wharton, a senior official at the National Center for Immunization and Respiratory Diseases, said at an FDA advisory committee meeting Thursday. 

The U.S. Is expected to shift Covid vaccine distribution to the private sector as soon as the fall, when the federal government's supply of free shots is expected to run out. Manufacturers will sell their updated jabs directly to health-care providers rather than to the government.

That doesn't include Johnson & Johnson, a once-leading Covid vaccine developer. The company's shots are no longer available in the U.S. After reports of rare but serious blood-clotting side effects.

For Pfizer and Moderna, the commercial market is an opportunity to tap into more distribution channels than they did under government contracts.

But both companies still expect Covid-related sales to decline this year as the world emerges from the pandemic and fewer people rely on vaccines and treatments. Pfizer expects Covid shot revenue to fall to $13.5 billion this year from $37.8 billion in 2022.

Moderna expects a minimum of $5 billion in revenue from its Covid vaccine, its only available product. The jab generated $18.4 billion in revenue last year.

For Novavax, the commercial market is crucial to its survival through 2023 and beyond. The cash-strapped company won U.S. Approval for its Covid vaccine under emergency use just last year due to regulatory and manufacturing delays. 

Now, one of Novavax's top priorities is to capture commercial market share after lagging behind Pfizer and Moderna. The FDA's strain selection positions Novavax as a viable competitor against those household names.

The company hopes to rake in $1.06 billion to $1.24 billion in sales of its Covid vaccine this year. That's slightly lower than the $1.5 billion Novavax's shot generated last year.

But the three companies still face the same hurdle: It's unclear how many Americans will roll up their sleeves to take updated vaccines later this year, even if those shots are delivered on time. 

Only around 17% of the U.S. Population — around 56 million people — have received Pfizer and Moderna's latest boosters since they were approved in September, according to the CDC. 

China's CSPC Pharma Partners With Pfizer For Oral COVID Treatment

(Reuters) - Chinese drug maker CSPC Pharmaceutical Group said on Thursday it signed a strategic partnership with Pfizer to launch a local brand of an oral COVID-19 treatment, in an attempt to improve the access for treatment in China.

The combination of Nirmatrelvir and Ritonavir sold under the brand name Paxlovid, an oral small molecule developed by pharmaceutical company Pfizer, is used to treat patients suffering from mild to moderate COVID-19 symptoms and who are at the risk of disease progression.

In December 2021, the U.S. Food and Drug Administration authorised the use of Paxlovid, making it the first drug for COVID-19 that can be taken at home.

China, whose home-grown vaccines are seen as less effective than the Moderna and Pfizer-BioNTech mRNA shots, has been racing to develop vaccines using messenger RNA (mRNA) technology since early 2020.

Earlier this year, CSPC said China had approved its first domestically developed mRNA vaccine against COVID-19, a major achievement in a country that has declined to use Western COVID shots to support domestic research.

(Reporting by Archishma Iyer in Bengaluru; Editing by Sherry Jacob-Phillips)

Moderna, Pfizer Sued Over Technology Developed By San Diego Researchers That Made COVID-19 Vaccine Possible

Moderna, Pfizer and BioNTech were named in lawsuits Tuesday that accuse them of stealing a patented method developed by researchers from The Scripps Research Institute that made the COVID-19 vaccine possible.

The two separate patent infringement lawsuits — one against Moderna for its Spikevax vaccine and one against Pfizer and its partner BioNTech for its Comirnaty vaccine — were filed in federal court in San Diego by Promosome. The firm, which has offices in San Diego and New York City, develops and commercializes discoveries from the late Nobel Prize laureate Gerald Edelman and Vincent Mauro both of whom conducted research at The Scripps Research Institute in La Jolla.

As of late Tuesday, Moderna, Pfizer and BioNTech could not be reached for comment on the lawsuit.

The patent at the center of the complaints is a novel method for modifying messenger RNA, or mRNA — which delivers instructions to a cell for protein production. The modification from researchers ultimately made mRNA vaccines safer and significantly more effective by helping the immune system produce sufficient proteins to fight the virus with small doses of mRNA. The technique was developed by Scripps scientists Edelman, Mauro, Stephen Chappell and Wei Zhou in 2009, the lawsuit states.

The lawsuit against Moderna contends that in 2013, under a confidential disclosure agreement, the patented method was shared with the biopharmaceutical company's highest leadership, including CEO Stéphane Bancel and President Stephen Hoge. However, Moderna did not license the technology.

The lawsuit filed against Pfizer and BioNTech alleges that in 2015, Promosome shared the technology with BioNTech scientist, Dr. Katalin Karikó, but neither company licensed the technology.

In each complaint Promosome seeks "to receive its rightful share of the tens-of-billions in revenues," each company "already has earned and countless billions it will earn by willfully infringing the '179 Patent."

Moderna netted $18.4 billion in sales for its coronavirus vaccine last year, according to SEC filings. Pfizer and BioNTech brought in $37.8 billion from sales of its COVID-19 vaccine, Comirnaty, last year.

"Our client's cutting-edge technology has helped spare hundreds of millions of people from the harmful effects of COVID-19," said Bill Carmody, lead lawyer on the matter and partner at the firm Susman Godfrey. "Unfortunately, these big pharma companies have failed to give Promosome what it deserves."

Patent infringement lawsuits are not uncommon in the realm of biotechnology and pharmaceuticals.

Multiple lawsuits have previously been filed related to the coronavirus vaccines and the technology that made it possible.

For example, in February Moderna paid the federal government $400 million for a chemical technique it employed in its COVID-19 vaccine. In August, Moderna sued Pfizer and BioNTech for patent infringement related to the mRNA technology used in its COVID-19 vaccine.

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