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Advanced registered practitioner with the Pfizer Covid-19 vaccine at the Amazon Meeting Center in Seattle.
Grant Hindsley / AFP through Getty Images
Despite growing concerns about the ability of new strains of the virus to force Covid-19 to escape the protections provided by the authorized vaccines,
Pfizer
maintains that he sees no evidence that the vaccine will be as effective.
In spite of,
Pfizer
(ticker: PFE) and his companion
BioNTech
(BNTX) announced Thursday that it had launched a small study aimed at determining whether the administration of the third dose of the company’s authorized Covid-19 vaccine can offer protection against different strains of the virus.
That’s a different approach than a competitive one
Moderna
(MRNA), which announced late Wednesday that doses of a new version of its vaccine were designed to protect against South African snoring ready for testing.
The Pfizer study, involving 144 patients, will administer an increased dose of the original Pfizer vaccine to participants from an earlier trial who received their first two doses between six and 12 months earlier. The company said its first patient received their third dose this week.
The company runs tests on serum extracted from the blood of test subjects to determine how well it neutralizes Covid-19-specific modifications in the laboratory. Their blood is taken and tested at baseline, and then after a week, and then again after a month.
The Food and Drug Administration has shown commitment in recent days to progressing vaccines that protect against the emerging variables. The group released new guidance Monday that will allow vaccine developers to use efficacy data on the original versions of their vaccines in their applications for emergency use permit for updated versions of their vaccines.
The guidance noted in particular how companies could seek approval for a Covid-19 vaccine increase equivalent to previous doses. The company says it will remain in talks with the FDA about what a regulatory pathway will look like.
Also on Thursday, Pfizer and BioNTech said they were in talks with regulators about a Phase 1/2 review of a new version of their vaccine designed to protect against the variant identified in South Africa. The company has not said that they have yet to develop such a new version of their vaccine, so the debate is largely speculative.
Pfizer competitors have already announced work on versions of their vaccines aimed at protecting against the South African virus strain. Moderna said Wednesday that the new version of its vaccine was ready for testing, though the company has also said it will test an increased dose of its original vaccine. Novavax says it plans to begin clinical trials of a booster or combination vaccine to protect against emerging strains in the second quarter of the year.
It seems that Pfizer, at the moment, is banking on a dose increase.
“While we have not seen any evidence that the changes in circulation are leading to a loss of protection provided by our vaccine, we are taking a number of steps to work with certainty and preparedness. in case strain protects the protection afforded by the vaccine, ”Pfizer CEO Albert Bourta said in a statement. “This enhancement study is critical to understanding third-dose safety and efficacy against circulating strains. At the same time, we are making the right investments and engaging in appropriate discussions with regulators to help us develop and seek approval. to increase or enhance mRNA vaccine if required. “
Shares of Pfizer are up 2.7% over the past 12 months, and down 8.2% so far this year.
Write to Josh Nathan-Kazis at [email protected]