Pfizer-BioNTech vaccine

Pfizer-BioNTech vaccine image courtesy of Wikipedia

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) have submitted data to FDA indicating that their vaccine is stable at –25° C to –15°C. Currently, the vaccine can be stored in an ultra-cold freezer between –80⁰ C and –60⁰ C, according to current CDC guidelines.

Updating the companies’ emergency use authorization prescribing information would be simplify logistics. It would enable vaccine vials to be stored in the warmer temperature range for up to two weeks, reducing the need for ultracold freezers, which are in short supply.

“The data submitted may facilitate the handling of our vaccine in pharmacies and provide vaccination centers an even greater flexibility,” said BioNTech CEO Ugur Sahin in a statement. “We will continue to leverage our expertise to develop potential new formulations that could make our vaccine even easier to transport and use.”

The FDA submission includes stability data based on vaccine batches produced over the past nine months.

The companies plan on sharing the data with other regulatory agencies in the coming weeks.

In related news, a new Israeli study published in The Lancet concluded that the Pfizer-BioNtech vaccine is 85% effective 15 to 28 days after a single dose.

That figure was substantially higher than the estimated efficacy of 52.4% for the first dose of the BNT162b2 mRNA vaccine based on clinical trial data.

The finding doesn’t mean that health authorities should administer only a single dose of mRNA vaccines or delay the second dose, said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID).

“Even though you can get a fair degree of protection after a single dose, it clearly is not durable,” Fauci said at a recent White House briefing.

Fauci also pointed out that the second vaccine dose generates roughly 10 times the level of neutralizing antibodies than the first dose.

Another worry is that suboptimal immunity from a single vaccine dose could make the virus harder to fight. “Because of the immunological pressure that you see on the virus [with suboptimal immunity], you might actually theoretically be inducing more variants,” Fauci said. “So, there are a few scientific reasons why we feel, given the information we have right now, we will stick with the scientifically documented efficacy and optimal response of a prime followed by a boost with the mRNA [vaccines].”