The Food and Drug Administration (FDA) could authorize Pfizer's updated COVID-19 boosters by the end of August, company CEO Albert Bourla said during an earnings call Tuesday.
Still, it's unclear if there will be widespread demand once the shot hits the market, underscoring softening sales from its portfolio of COVID-19 products.
"Clearly, there is a higher level of uncertainty regarding the demand projections for our COVID-19 products than for the rest of the business," Bourla said in the call.
For example, Bourla in January said he expected that approximately 100 million doses of COVID-19 vaccines would be administered in the U.S. this year, 60 percent of which were expected to be Pfizer's.
But in the first six months of the year, just 12.4 million doses were administered.
Pfizer reported second-quarter sales of $12.73 billion, down 54 percent from the same period last year.
“The contraction in revenues was driven by the anticipated decline in Paxlovid and Comirnaty sales,” Pfizer's CFO David Denton said. Comirnaty is the name under which Pfizer's shot is marketed.
According to the company, its vaccine earned $1.49 billion in sales, down 83 percent from this time last year. The antiviral pill Paxlovid posted $143 million in revenue, a drop of 98 percent.
However, the vast majority of respiratory vaccinations happen during the fall and winter respiratory disease season, which starts in September, "and we expect COVID-19 vaccinations to follow this pattern going forward," Bourla said.
Bourla said the second half of the year will also play a bigger role in determining the long-term demand for Paxlovid, use of which follows very closely the COVID-19 infection rates.
"We expect a new COVID-19 wave to start in the U.S. this fall, and this expectation is supported by the increase in infection rates we are already seeing," Bourla said.
The federal government is no longer paying for COVID-19 vaccines with the end of the pandemic public health emergency. That means the vaccines are now only available on the commercial market.
The company sells Paxlovid to the government for about $530 for a five-day course of treatment, but it has not said what it will charge commercially.
Last month, the Food and Drug Administration told vaccine manufacturers that their coronavirus vaccines for this fall should target XBB.1.5, though it is no longer the dominant strain, only making up 12.3 percent of all new COVID infections through the week ending July 22, according to the Centers for Disease Control and Prevention.
The newly dominant strain is XBB.1.16, which accounts for about 15 percent of all new cases.
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