Moderna, Pfizer, J&J talk omicron response

Pharmaceutical giants evaluating current vaccines, developing omicron-specific booster candidates

As COVID-19's new omicron variant has begun to emerge overseas, vaccine makers Moderna, Pfizer and Johnson & Johnson have outlined their respective strategies to tackle the new strain.

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Moderna, which has an authorized booster dose at the 50 microgram (µg) dose level for adults ages 18 years or older, has already completed dosing of 309 participants in a safety and immunogenicity study testing a 100 µg booster dose. 

The company is also studying two multi-valent booster candidates, mRNA-1273.211 and mRNA-1273.213, which are designed to anticipate mutations such as those that have been identified in omicron. The first candidate has completed dosing at the 100 and 50 µg levels, while the latter completed dosing at the 100 µg level and is planning to explore the 50 µg level in approximately 584 participants. 

In addition, Moderna plans to rapidly advance an omicron-specific booster candidate, mRNA-1273.529, which it estimates could reach clinical testing within 60 to 90 days. 

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"From the beginning, we have said that as we seek to defeat the pandemic, it is imperative that we are proactive as the virus evolves," Moderna CEO Stéphane Bancel said. "The mutations in the omicron variant are concerning and for several days, we have been moving as fast as possible to execute our strategy to address this variant." 

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Meanwhile, a Pfizer spokesperson told FOX Business the company has started to run neutralization tests on the new omicron variant of concern and expects to have initial data in the coming weeks. Like Moderna, Pfizer and BioNTech have an approved booster dose at the 50 µg dose level for adults ages 18 years or older. 

In addition, Pfizer submitted an application for an emergency use authorization of its antiviral COVID-19 pill Paxlovid, which showed nearly a 90% reduction in hospitalization and death in a recent study. A spokesperson for the company confirmed to FOX Business that it expects Paxlovid to be effective against the omicron variant and that it will manufacture 80 million courses of the pill, up from its original goal of 50 million. The Biden administration has already bought 10 million courses of Paxlovid in a $5.29 billion agreement announced earlier this month.

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"As always, we will continue to follow the science as we examine the best approaches to protecting people against COVID-19," the spokesperson added. "In the event that a variant emerges that escapes protection of our vaccine, Pfizer and BioNTech expect to be able to develop and produce a tailor-made vaccine against that variant in approximately 100 days, subject to regulatory approval."

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As for Johnson & Johnson, the company is partnering with academic groups in South Africa and around the world to evaluate the effectiveness of its COVID-19 vaccine across variants, including omicron. Johnson & Johnson is testing blood serum from participants in completed and ongoing booster studies and is also pursuing an omicron-specific variant vaccine and will progress it as needed.

"We remain confident in the robust humoral and cell-mediated immune responses elicited by the Johnson & Johnson COVID-19 vaccine demonstrated by the durability and breadth of protection against variants to date in clinical studies," Global head for Janssen research and development Mathai Mammen said. "We will not be complacent. Building on our long-term collaboration with scientists on the ground in South Africa and the ongoing real world effectiveness studies being conducted with the Johnson & Johnson COVID-19 vaccine, we will work together to generate new data on omicron."

The U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) has recommended the Johnson & Johnson COVID-19 vaccine as a booster for all eligible individuals ages 18 years or older who received an authorized COVID-19 vaccine.

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Approximately 37.5 million adults ages 18 or older have received a booster dose to date, according to the CDC, representing 19.1% of the total U.S. population. Individuals ages 18 or older should get a booster shot 6 months after their second dose of a Pfizer-BioNTech or Moderna vaccine or 2 months after their initial J&J vaccine.

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Scientists know that omicron is genetically distinct from previous variants, including beta and delta, but don’t know if these genetic changes make it any more transmissible or dangerous. So far, there is no indication the variant causes more severe disease. 

To date, delta is by far the most predominant form of COVID-19, accounting for more than 99% of sequences submitted to the world’s biggest public database.

The Associated Press contributed to this report