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Pfizer’s board member Dr Scott Gottlieb told CNBC on Thursday that the company is researching two separate methods to try to provide vaccine protection against newer variants of the coronavirus.
In an interview with “Squawk Box,” Gottlieb said the first approach focused on whether a booster shot using the current two-dose vaccine formulation would provide additional defense. Pfizer and its German partner BioNTech announced earlier Thursday a trial examining precisely this.
“There is reason to believe that you will get additional protection only from a booster of the existing vaccine against these new variants,” said Gottlieb, former Commissioner of the Food and Drug Administration in the Trump administration.
The second attempt is to modify the existing vaccine in a way that could provide stronger immunity against viral mutations, Gottlieb said. The companies said in a statement Thursday that they were in discussions with regulators to initiate the research study.
While the new coronavirus variants are of concern to public health officials, particularly the most contagious strain first found in South Africa, Gottlieb said any changes to the vaccine formulation would hope to offer broad protection.
“What you want to do is not necessarily develop a vaccine that is [B.1.351], the change we’ve seen in South Africa, ”said Gottlieb, who led the FDA from 2017 to 2019.“ What you want to do is develop a protein sequence that is sort of a consensus sequence and that incorporates enough changes so we’ve seen around the world that you have a protective vaccine, no matter what the virus manages to do against itself. “
The variant of the virus discovered in South Africa is widely believed to present a greater challenge to existing vaccines than other newer strains, such as the one originally found in the UK.
For example, Johnson & Johnson reported that their vaccine was 72% effective in preventing symptomatic Covid in the United States and 57% in South Africa, where the B.1.351 strain is dominant. However, the vaccine provided 85% protection against severe Covid throughout the trial, part of which was also conducted in regions of Latin America where different variants are present.
The U.S. FDA is expected to clear J & J’s vaccine for emergency use soon after the agency’s vaccine advisory committee meeting scheduled for Friday.
The vaccines from Pfizer-BioNTech and Moderna – which already have emergency use authorization in the United States – underwent large phase three trials before the new variants were discovered. However, Pfizer and BioNTech conducted a study examining the variant found in South Africa, which suggested some reduction in antibody production even though the vaccine still neutralized the virus.
Additionally, Moderna said its two-dose vaccine appears to generate a weaker immune response against the South African variant, while adding that the antibody response remains at levels believed to provide protection.
Moderna announced on Wednesday that it had shipped a modified version of its vaccine to the National Institutes of Health to begin various variant protection studies. Similar to Pfizer, the company said it will also test a low-dose booster of its current two-dose formulation.
Limited dose availability has been a barrier to delivering Covid injections to more people once regulatory clearance is given. In the United States, in particular, this situation has improved as companies ramp up production, and Gottlieb noted that the eventual approval of J & J’s single-dose vaccine will also be helpful in expanding access.
If a booster injection is needed to provide better protection against the variants, Gottlieb has expressed confidence in the potential availability of the assay. “I don’t think we’ll have to ration the supply if we’re going to give people a third reminder in the fall,” he said.
“The challenge will be to think about the new variant vaccine and whether – and when – you would or would not switch to making this vaccine, and how much you would produce,” Gottlieb said. “This will be a decision you will need to make before these new vaccine variants are likely to be permitted. You may not want to change your entire manufacturing, but part of it.” He added: “Probably over the summer you will have to make that decision.”
Disclosure: Scott Gottlieb is a CNBC contributor and is a member of the board of directors of Pfizer, a genetic testing start-up Tempus, health technology company Aetion and biotechnology company Illumina. He is also co-chair of the Healthy Sail Panel for Norwegian Cruise Line Holdings and Royal Caribbean.
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