“Pfizer Inc. said it plans to ask U.S. health regulators on Friday to permit use of its Covid-19 vaccine, a milepost in months of frantic efforts to find a medicine that could beat back a rampaging pandemic,” WSJ writes.
The ball is in the FDA’s court now. Once Pfizer files, the FDA will start to conduct its official review. The timeline is unclear, but the regulator is expected to move quickly, and projections still fall in line with authorization and distribution beginning next month.
- If approved, Pfizer and BioNTech’s efforts would mark the fastest vaccine development program ever in the West. The companies have spent roughly $2 billion on development, which could go from the lab to public use in less than a year.
- The general public would likely get access to the shots sometime in the spring or summer.
But while Pfizer’s vaccine is taking one step forward, Gilead’s remdesivir takes two steps back. On Thursday, the World Health Organization recommended against using the antiviral drug to treat Covid-19, WSJ reports.
Why? A panel of international experts that advises the WHO on treatments didn’t find any evidence that remdesivir reduces deaths or recovery times.
- “[Remdesivir] has no meaningful effect on mortality or on other important outcomes for patients, such as the need for mechanical ventilation or time to clinical improvement,” the WHO said.
Gilead fired back, saying its drug is “recognized as the standard of care for hospitalized Covid-19 patients by health organizations in the U.S., Japan, U.K. and Germany, based on multiple studies published in peer-reviewed journals.”
- Remdesivir received an emergency-use tag in May before getting full approval in October.
The Bottom Line: The WHO said more data is needed to prove that remdesivir indeed helps patients. But for now, the WHO stands by its recommendation because of the “risk of side effects, high cost and labor required to administer the intravenous therapy.”
See the November 19, 2020 Morning Cents for more on the vaccines and vaccine companies.
Gilead ($GILD) stock looks cheap at 6.5x EBITDA with a 12.4% free cash flow yield, but the stock has declined by 40% over the last 5 years because of material declines in its antiviral drug business (hepatitus, HIV, etc). Unless you believe they can find new antiviral growth avenues, possibly with Covid-19 treatments, then I’d pass on this one.