The companies have said they should be able to produce 1.3 billion pods. (Representative)
The Covid-19 vaccine under development 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 to date in the fight against coronavirus.
Eight months after the start of the worst pandemic in a century, preliminary results pave the way for companies to seek emergency use authorization from regulators if further research shows the shot is also safe.
Shares of Pfizer extended their gains in pre-market trading, up about 7%, as BioNTech’s U.S. certificates of deposit rose about 11%.
The results 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 safety key reading Pfizer expects in about a week’s time also looks good, it could mean the world has a vital new tool to control a pandemic that has killed more than 1.2 million. people around the world.
“This is about the best news could be for the world, for the United States and for public health,” said William Gruber, Pfizer’s senior vice president for clinical vaccine research and development. . It was better than even the best result he had hoped for, he said.
The effectiveness of the first vaccines to be between 60% and 70%, “more than 90% is extraordinary,” said Ugur Sahin, CEO of BioNTech.
‘Victory of science’
“It shows that Covid-19 can be controlled,” Sahin said in an interview. “In the end, it really is a victory for science.”
Data has limits. For now, few details on the effectiveness of the vaccine are available. It is not known how well shooting works in key subgroups, such as the elderly. These analyzes were not performed. And it is not known whether the vaccine prevents serious illness, as none of the participants who contracted Covid-19 in this round of analyzes had serious cases, Gruber said.
However, the strong read from the first large-scale trial to published efficacy results bodes well for other experimental vaccines, particularly one developed by Moderna Inc. which uses similar technology. Its large trial could generate efficacy and safety results within weeks. If this study is also successful, there could be two vaccines available in the United States by the end of the year.
Pfizer expects to obtain two months of safety tracking data, a key measure required by U.S. regulators before an emergency clearance is granted, during the third week of November. If there are no problems with these results, Pfizer could seek clearance in the United States this month. An ongoing review began in Europe last month, and Sahin said regulators are working with BioNTech to “further speed up the process.”
So far, the trial’s data oversight committee has not identified any serious safety issues, Pfizer and BioNTech said.
Lead the race
Positive preliminary data means the US pharmaceutical giant and its German partner are on track to be the first with a vaccine, having signed pre-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 shot relies on messenger RNA technology never before used in an approved drug. The use of mRNA, which essentially teaches cells in the body to become vaccine factories, has made it possible to develop it much faster than a traditional vaccine.
Pfizer had initially planned to conduct an initial analysis of the trial data after only 32 cases of the virus occurred in the trial, which recruited 43,538 volunteers from several countries. The analysis of the data proved controversial among medical experts early on. Other companies working on vaccines planned to wait longer before reviewing trial information.
After discussions with U.S. regulators, Pfizer and BioNTech said they recently opted to drop the 32-case analysis and conduct the first analysis on a minimum of 62 cases, one of many changes to the plan. analysis of tests.
While Pfizer led those negotiations, it suspended testing of participant samples for the virus, Gruber said. By the time Pfizer made the changes to the testing plan and relaunched virus testing a few days ago, some 94 cases had occurred, far more than the testing needed to reach the new threshold.
Pfizer ran to verify the data, which was still blind to almost everyone in the business alongside a few statisticians. Early Sunday afternoon, an independent data monitoring committee that included a renowned statistician and four infectious disease experts met in a closed-door video session to examine the results for the first time. Afterwards, the panel summoned Gruber, Sahin and other company representatives and told them that the vaccine had easily reached its goal of effectiveness.
“Everyone is thrilled,” said Gruber. He said more details on the breakdown of cases were not available.
Duration uncertain
The vaccine is tested on a two-dose schedule. The trial began 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 found itself embroiled in a controversial political debate over how quickly U.S. regulators should allow a vaccine to be administered to Americans. President Donald Trump pushed for a shot to be approved before Election Day, but regulators put in place tough standards that largely pushed that target out of reach.
On October 16, Pfizer CEO Albert Bourla said companies could apply for emergency use authorization from U.S. regulators by the end of November if the results of the trial show the shot to be safe and effective. . By writing in an open letter, Bourla allayed fears that Pfizer would race against time to release a vaccine ahead of the presidential election.
Moderna is considered to be the next closest vaccine leader. He said he could get data on the safety and effectiveness of his late-stage trial this month. Johnson & Johnson, which has a single-dose vaccine using different technology, could obtain efficacy data from a final trial by the end of this year. AstraZeneca Plc is also working on a vaccine using different technology, with results from studies in the UK and Brazil expected by the end of the year.
(Except for the title, this story was not edited by GalacticGaming staff and is posted from a syndicated feed.)
