Pfizer could win US COVID vaccine approval, J&J to come later

US President Donald Trump on Monday suggested Pfizer Inc could secure the first US approval of a COVID-19 vaccine in coming weeks, saying a contender by Johnson & Johnson could come later.

Asked which drugmaker could be approved, Trump told Fox News in an interview: “Pfizer’s doing really well,” adding “Johnson & Johnson … they’ll probably be a little later.” He also cited efforts by Moderna Inc and AstraZeneca Plc.

Meanwhile, Pfizer is betting that its coronavirus vaccine candidate will show clear evidence of effectiveness early in its clinical trial, according to the company and internal documents reviewed by Reuters that describe how the trial is being run.

In recent weeks, Pfizer has said it should know by the end of October whether the vaccine, developed together with Germany’s BioNTech SE, is safe and effective. If the vaccine is shown to work by then, Pfizer has said it would quickly seek regulatory approval. It has not said what data it would use.

The FDA has said that a coronavirus vaccine must prove to be at least 50 percent more effective than a placebo in a large-scale trial to be considered for approval. However, a smaller sample of infections in a clinical trial changes the calculation of how that standard is met, according to researchers.

Pfizer’s vaccine would need to be at least 76.9% effective to show it works based on 32 infections, according to its protocol. That would mean that no more than six of those coronavirus cases would have occurred among people who received the vaccine, the documents showed.

As for Moderna, the company said earlier that it was on track to produce 20 million doses of its experimental coronavirus vaccine by the end of the year, while maintaining its goal of readying 500 million to 1 billion doses in 2021.

Moderna has a vaccine supply deal in place with the U.S. for 100 million doses, and has finished advanced talks with the European Union for the vaccine.

On the other hand, AstraZeneca set its first interim analysis when about 40 coronavirus infections are reported among participants. Its U.S. trial is currently on hold after a patient fell ill.

Vaccines and treatments are seen as essential in controlling the COVID-19 pandemic that has shown no signs of slowing and killed over 944,000 people worldwide. – Reuters

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