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A vaccine developed by Pfizer and BioNTech SE protects most people from Covid-19, according to a study whose early findings sent stock prices up and was hailed by America’s leading infectious disease specialist as ” extraordinary “.
The vaccine prevented more than 90% of symptomatic infections in the trial of tens of thousands of volunteers, the most encouraging scientific advance yet in the battle against the coronavirus. While the results are preliminary, they may pave the way for companies to seek an emergency use authorization if further research shows the vaccine is also safe.
Pfizer shares rose as much as 15% and were trading 8.8% higher as of 3:14 pm in New York, while BioNTech American’s depository receipts rose as much as 24%. The news fueled a global rally that added more than $ 1.8 trillion to the value of the MSCI All Country World Index.
The findings are based on an interim analysis conducted after 94 of the 43,538 trial participants, divided between those who received a placebo and those who were vaccinated, 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.
With the effectiveness of early vaccines previously expected to be in the 60% to 70% range, a rate of more than 90% “is just extraordinary,” said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, in a call with reporters.
Data has limits. It is not known how well the vaccine works in key subgroups, such as the elderly. 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 such cases, said William Gruber, Pfizer’s senior vice president for clinical vaccine research and development.
Outside researchers said they would need much more data, including safety information, to assess how good the vaccine is. Assuming the first encouraging results hold up and the vaccine is approved, use in the general public would still be a long way off, and those most at risk are likely to contract it first.
“So far, it looks promising,” said Peter Jay Hotez, a vaccine researcher and dean of the National School of Tropical Medicine at Baylor College of Medicine. “It helps provide proof of concept that it is possible to make a human Covid-19 vaccine.”
Assuming the vaccine clears the final hurdles, attention will quickly shift to its implementation worldwide. The challenges will be immense: The companies have agreed to offer deals with the US government and other countries, but front-line medical personnel, essential workers and at-risk groups are expected to receive any licensed vaccines first.
The US states have been working on distribution plans, but many cannot finalize the arrangements until it is clear what opportunity will be given, as the leading candidates have different storage and transportation requirements. Pfizer’s vaccine, for example, must be kept at ultra-cold temperatures.
“Vaccine launch requires near-perfect execution of a chain of interconnected processes,” according to an Oct. 21 report from the Boston Consulting Group. In addition to handling the products, officials will need to organize outreach and public education campaigns, monitor whether vaccines have any safety or efficacy issues once they reach a wider population, and
Two injection regimen
The Pfizer vaccine is being tested on a two-dose regimen. The trial began in July, and since most of the participants only received their second dose much more recently, no one knows how long the protection will last.
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. A continuous review is taking place in Europe.
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 American 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. Around 50 million doses are expected to be available in 2020.
“It shows that Covid-19 can be controlled,” BioNTech CEO Ugur Sahin said in an interview. “At the end of the day, it really is a victory for science.”
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 October 16, Pfizer Chief Executive Officer Albert Bourla said that companies could apply for an emergency use authorization from US regulators by the end of November if the test results showed the injection to be safe and effective.
Donald Trump Jr and Senator Ted Cruz questioned whether the data was released on Monday after the election. “Because right now?” asked the senator, and the president’s son called the moment “quite surprising.”
Pfizer and BioNTech have a $ 2 billion agreement to supply 100 million doses to the US, with an option for a further 500 million. Among the pioneers, his is the only vaccine project that did not receive funding from the Operation Warp Speed program run by the White House to boost research, development or manufacturing. However, BioNTech received up to 375 million euros ($ 445 million) in development funding from the German government.
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 virus cases had occurred in the trial, which has enrolled 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 remove the 32-case threshold and conduct the first analysis on a minimum of 62 cases. The evaluation focuses on symptomatic Covid-19 infections, not just those that test positive.
94 cases
While Pfizer conducted those negotiations, it paused testing 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 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.
© 2020 Bloomberg
