Dr. Scott Gottlieb on Pfizer’s efforts to get a 3rd Covid vaccine
Pfizer board member Dr. Scott Gottlieb told CNBC on Thursday that the company is researching two different methods to provide vaccination protection against new coronavirus variants.
In an interview on Squawk Box, Gottlieb said the first approach focused on whether a booster shot using the current formulation of the two-dose vaccine would provide additional defense. Pfizer and its German partner BioNTech announced a test that was not examined until early Thursday.
“There is reason to believe that just boosting the existing vaccine against these new variants will give you extra protection,” said Gottlieb, a former Food and Drug Administration commissioner in the Trump administration.
The second endeavor is to modify the existing vaccine so that stronger immunity to virus mutations can be achieved, explained Gottlieb. The companies announced in a press release on Thursday that they are discussing the launch of this research study with regulators.
While new coronavirus variants affect public health officials, particularly the contagious strain first found in South Africa, Gottlieb said any change to the vaccine formulation would offer broad protection.
“What you want to do is not necessarily develop a vaccine that is specifically against [B.1.351], the change we’ve seen in South Africa, “said Gottlieb, who headed the FDA from 2017-2019.” You want to develop a protein sequence that is sort of a consensus sequence and that incorporates enough of the changes we’ve seen around the world that you have a vaccine that protects no matter what the virus does against itself. “
It is widely believed that the virus variant discovered in South Africa poses a greater challenge to existing vaccines than other new strains, such as the one originally discovered in the UK
For example, Johnson & Johnson reported that their vaccine was 72% effective in preventing symptomatic Covid in the US and 57% in South Africa, where the B.1.351 strain dominates. However, the vaccine provided 85% protection against severe Covid throughout the trial. Part of this has also been carried out in regions of Latin America where different variants exist.
The U.S. FDA is expected to use J & J’s vaccine soon after the agency’s emergency vaccine board meeting scheduled for Friday.
Pfizer-BioNTech and Moderna vaccines, which already have an emergency approval in the US, were tested in large phase three studies before the new variants were discovered. However, Pfizer and BioNTech conducted a study examining the variant found in South Africa. This indicated some reduction in antibody production, even though the vaccine was still neutralizing the virus.
In addition, Moderna has said that its two-dose vaccine appears to produce a weaker immune response against the South African variant, while adding that the antibody response remains at levels believed to provide protection.
Moderna announced Wednesday that it has shipped an optimized version of its vaccine to the National Institutes of Health to start various studies on variant protection. Similar to Pfizer, the company will also be testing a lower-dose booster shot of its current two-dose formulation.
Limited available doses have been a barrier to covid shots being given to more people once government approval has been granted. In the U.S. in particular, that situation has improved as companies ramp up production, and Gottlieb noted that J & J’s possible approval of the single-dose vaccine will also help expand access.
Should a booster shot be needed to ensure better protection against variants, Gottlieb was confident that the dosage might be available. “I don’t think we have to ration supplies if we want to give people a third booster in the fall,” he said.
“The challenge will be to think about the new vaccine variant and whether and when you would switch to this vaccine and how much you would produce,” said Gottlieb. “That will be a decision you need to make before these new variants of vaccines are likely to get approved. You may not want to switch all of your manufacturing, but you want to switch some of it.” He added, “You will likely have to make that decision sometime this summer.”
Disclosure: Scott Gottlieb is a CNBC employee and a member of the boards of directors of Pfizer, genetic testing startup Tempus, healthcare technology company Aetion, and biotech company Illumina. He is also co-chair of the Healthy Sail Panel of Norwegian Cruise Line Holdings and Royal Caribbean.