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The Covid-19 vaccine being developed by Pfizer Inc. and BioNTech SE prevented more than 90% of infections in a study of tens of thousands of volunteers, the most encouraging scientific advance yet in the battle against the coronavirus.
Eight months after the worst pandemic in a century, preliminary results pave the way for companies to seek an emergency use authorization from regulators if further research shows the injection is also safe.
Pfizer stock expanded earnings in premarket operations, increasing about 7%, with BioNTech American’s depository receipts up 11%.
The findings are based on an interim analysis conducted after 94 participants contracted Covid-19. The trial will continue until 164 cases have occurred.
If the data holds up and a key safety reading that Pfizer expects in about a week looks good too, it could mean the world has a vital new tool to control a pandemic that has killed more than 1.2 million people across the world. world.
“This is the best news that could be for the world and for the United States and for public health, ”said William Gruber, Pfizer’s senior vice president of clinical vaccine research and development. It was even better than the best result he had hoped for, he said.
With the effectiveness of early vaccines expected to be in the 60-70% range, “more than 90% is remarkable,” said BioNTech CEO Ugur Sahin.
‘Victory of science’
“It shows that Covid-19 can be controlled,” Sahin said in an interview. “At the end of the day, it really is a victory for science.”
Data has limits. For now, few details are available about the vaccine’s effectiveness. It is not known how well the vaccine works in key subgroups, such as the elderly.
Those analysiss have not been performed. And it is not known whether the vaccine prevents severe disease, as none of the participants who received Covid-19 in this round of analysis had severe cases, Gruber said.
However, the strong read from the first large-scale trial to publish efficacy results bodes well for other experimental vaccines, particularly one being developed by Moderna Inc. that uses similar technology.
Their large trial could generate efficacy and safety results within weeks. If that study is also successful, there could be two vaccines available in the US around the end of the year.
Pfizer expects to obtain two months of safety tracking data, a key metric required by US regulators before an emergency authorization is granted, in the third week of November.
If those findings pose no problems, Pfizer could apply for a US authorization this month. An ongoing review began in Europe last month, and Sahin said regulators are working with BioNTech to “further accelerate the process.”
So far, the trial’s data monitoring committee has not identified serious safety issues, Pfizer and BioNTech said.
Leading the race
Preliminary positive data means the US pharmaceutical giant and its German partner are on track to be first with a vaccine, after signing advance agreements with governments around the world for hundreds of thousands of doses.
The companies have said they should be able to produce 1.3 billion doses, enough to vaccinate 650 million people, by the end of 2021. Only 50 million doses are expected to be available in 2020.
The injection is based on messenger RNA technology never before used in an approved drug. The use of mRNA, which essentially teaches the body’s cells to become vaccine factories, allowed it to develop much faster than a traditional vaccine.
Pfizer had originally planned to conduct a first analysis of the trial data after only 32 cases of the virus had occurred in the trial, which has enrolled 43,538 volunteers in multiple countries.
The data analysis soon proved controversial among medical experts. Other companies working on vaccines planned to wait longer before analyzing the data from the trials.
After discussing with US regulators, Pfizer and BioNTech said they recently chose to drop the analysis of 32 cases and perform the first analysis on a minimum of 62 cases, one of several changes made to the test analysis plan.
While Pfizer conducted those negotiations, it paused testing of participants’ samples for the virus, Gruber said.
By the time Pfizer made the changes to the test plan and restarted virus testing a few days ago, there had been about 94 cases, far more than the test needed to reach the new threshold.
Pfizer was quick to verify the data, which was still blinded to almost everyone in the company, plus some statisticians.
Early Sunday afternoon, an independent data monitoring committee that included a famous statistician and four infectious disease experts met in a closed video session to review the results for the first time.
The panel later invited Gruber, Sahin and other company representatives to the call and told them that the vaccine had easily achieved its efficacy goal.
“Everybody is very excited,” Gruber said. It said no further details on the breakdown of the case were available.
Duration uncertain
The vaccine is being tested on a two-dose regimen. The trial started in July, and since most participants only received their second dose much more recently, no one knows how long the protection will last.
Pfizer has been embroiled in a contentious political debate about how quickly US regulators should allow a vaccine to be administered to Americans.
President Donald Trump pushed for a vaccine to be approved before Election Day, but regulators set rigorous standards that largely put that goal out of reach.
On Oct. 16, Pfizer Chief Executive Officer Albert Bourla said companies could apply for an emergency use authorization from US regulators by the end of November if the test results show the injection is safe and effective.
In an open letter, Bourla quelled fears that Pfizer may be speeding up the timing of a vaccine before the presidential election.
Moderna is considered the next pioneer in vaccines. It has said it could get safety and efficacy data from its late-stage trial this month. Johnson & Johnson, which has a single-shot vaccine with a different technology, could get efficacy data from an end-stage trial later this year.
AstraZeneca Plc is also working on a vaccine that uses a different technology, and the results of studies in the UK and Brazil are expected by the end of the year.
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