Latest updates: 15 confirmed cases of UK variant in Turkey; 613 reported Covid-related deaths in the UK; earlier curfews enforced by France in 15 departments
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Reuters reports that Pfizer Inc and BioNTech are preparing to give volunteers who received a placebo in their Covid 19 vaccine trial the option of obtaining the first dose of the vaccine by March 1, 2021, while remaining in the trial.
The “Vaccine Transition Option” trial offers all participants 16 years of age and older the opportunity to find out whether they received the placebo “and for participants who learn they received the placebo to have the option to receive the investigational vaccine while remaining in the trial,” the companies said on their website.
The U.S. Food and Drug Administration (FDA) and a group of its external advisors also raised concerns about the “unblinding” strategy of Pfizer, saying it may make it harder to continue gathering data on safety and efficacy required for the vaccine to be completely accepted by the FDA.
Participants in the study who received placebo will receive two doses of the investigational vaccine, the companies said on their website, as part of the experiment.
“The study physician will follow the latest guidelines from the U.S. Centers for Disease Control and Prevention and local health departments to offer the Vaccine Transition Option to participants in a prioritized manner,” the companies said.
On Friday, Dr. Anthony Fauci, the top U.S. infectious disease specialist, told CNN that the United States will not follow the example of the United Kingdom by putting forward the first vaccine injection, possibly delaying the second dose administration.
The U.K. this week. It has announced plans to postpone the second vaccination of its two approved vaccines, produced by Pfizer/BioNTech and Oxford/AstraZeneca, to offer partial single-dose protection to more individuals.
“I would not advocate that,” said Dr. Fauci. “We will continue to do what we are doing.”
Although the efficacy of the second dose was tested in clinical trials three or four weeks after the first, the U.K. Officials said a delay of up to 12 weeks would be permitted.
In trials, such delays have not been rigorously tested. For instance, when given in two doses three weeks apart, Pfizer’s vaccine showed 95 percent efficacy in preventing covid-19.
The advantage of the second vaccination, which is intended to increase the body’s protection against coronavirus and increase the intensity and resilience of the immune response, could be negated by a longer interval between vaccine doses.
The protective effects of the first vaccine, meanwhile, could also decrease faster than expected.
The (paywall) New York Times has the story.
In the United Kingdom, approximately two million doses of the Covid-19 vaccine, produced by Oxford University and AstraZeneca, are expected to be distributed. The Times reports each week through mid-January.
The newspaper announced that AstraZeneca plans to produce a total of two million doses of the vaccine by next week, citing an unidentified Oxford/AstraZeneca team member. “The plan then is to build it up pretty quickly – by the third week of January we should be up to two million a week,” the study added.
To respond to a Reuters request for comment, the company was not immediately available.
The study comes after Britain on Wednesday approved the Covid-19 vaccine from Oxford/AstraZeneca in hopes that rapid action would help curb a record surge of infections caused by a highly infectious form of the virus.
Under an agreement with AstraZeneca, Prime Minister Boris Johnson has ordered 100 million doses for the region. In the first quarter, the company said it intended to distribute millions of doses, adding that the first vaccines are scheduled to start later this year.
For the past four days, the U.K., which has seen more than 50,000 new cases of Covid-19 every day, has been dealing with the rapid spread of a far more contagious coronavirus variant.
As of Friday, the United Kingdom had reported 53,285 new cases of Covid-19 and another 613 fatalities.
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