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Coronavirus update: J&J applies for vaccine emergency use; FDA to address variants

Anjalee Khemlani
·Senior Reporter
·3 min read
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Johnson & Johnson (JNJ) has applied for emergency use authorization of its single-dose COVID-19 vaccine, which could be the third vaccine to roll out in the U.S.

A vaccine advisory committee of the U.S. Food and Drug Administration (FDA) is set for February 26. Previous vaccines were authorized within a day of the advisory meeting, which could mean a rollout of the vaccine by end of February at the earliest.

Chief scientific officer of J&J, Dr. Paul Stoffels, said the company would be ready to ship doses once authorized.

“With our submission to the FDA and our ongoing reviews with other health authorities around the world, we are working with great urgency to make our investigational vaccine available to the public as quickly as possible,” Stoffels said in a statement late Thursday.

Unlike Pfizer’s (PFE) and Moderna’s (MRNA) vaccine, J&J has less burdensome storage requirements, and is only a single dose vaccine. The company reported 66% efficacy overall, with 72% efficacy in its U.S. trial.

The company also revealed that the vaccine, while it held up against emerging variants, saw its efficacy diminish in South Africa, where the concerning B.1.351 strain originated.

Variants are of increasing concern, with many companies either pursuing a booster shot or new vaccine to address mutations.

FDA Acting Commissioner Dr. Janet Woodcock said Thursday the agency is working on guidelines to address tweaks to authorized treatments and vaccines as needed, as well as looking for areas of regulatory flexibility.

“We are aware that some of the neutralizing monoclonal antibodies that have been authorized or are under development are less effective against some of the COVID-19 variants that have emerged, and we are working with drug developers to accelerate the evaluation of new antibodies that could be effective against mutations,” she said.

Apprentice Nursing's Associate Ellie Bull administers the Astra Zeneca vaccine to a homeless person at the Wellcome Centre in Ilford, east London, Friday, Feb. 5, 2021. The British health service NHS England have started to vaccinate homeless vulnerable people. (AP Photo/Frank Augstein)
Apprentice Nursing's Associate Ellie Bull administers the Astra Zeneca vaccine to a homeless person at the Wellcome Centre in Ilford, east London, Friday, Feb. 5, 2021. The British health service NHS England have started to vaccinate homeless vulnerable people. (AP Photo/Frank Augstein)

COVID-19 Treatments and tests

Gilead (GILD) reported that 50% of hospitalized COVID-19 patients is being treated with Veklury (remdesivir), the only approved treatment to-date. The sales of the drug, with a price tag of more than $2,000, has been a boon for the company as the virus impacted other product sales, company officials said late Thursday.

Veklury delivered $1.9 billion in fourth quarter sales, up from $873 million the prior quarter, and the company estimates $2 billion to $3 billion in 2021 sales.

Chief medical officer Merdad Parsey noted on an earnings call that the treatment’s effectiveness does not appear to be impacted by variants spreading throughout the U.S.

The company has been working on an inhaled version of Veklury, which requires an entirely new set of clinical trials from the currently approved product. The product is currently in Phase 1, but company officials didn’t provide a timeline of how quickly it could go through the process.

Meanwhile, more funding is being provided to at-home testing options, even as one already authorized by the FDA faces a delayed rollout to retail sites.

Visby Medical announced its dual flu and COVID-19 at-home PCR test received a boost form the federal government, with $12.3 million awarded by the Biomedical Advanced Research and Development Authority (BARDA) to speed up production. The contract can be extended to as much as $48.7 million over a period of 38 months. The rapid test can provide results in 30 minutes, and uses the gold standard technology, PCR, for highly accurate results.

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