(Bloomberg) – A vaccine developed by Pfizer Inc. and BioNTech SE protects most people from Covid-19, which, according to a study of early findings that caused stock prices to skyrocket and was hailed as “extraordinary” by leading US infectious diseases expert. .
The drug prevented more than 90% of symptomatic infections in trials of tens of thousands of volunteers, the most encouraging scientific progress to date in the fight against coronavirus. While the results are preliminary, they could pave the way for companies to seek emergency permits if further research shows that vaccines are also safe.
Pfizer shares rose 8% in early trading, with BioNTech US custody receipts up about 19%. This news added over $ 500 billion to the value of the MSCI National World Index.
Encouraging results with vaccines could mean Having a tool to control viruses
The findings were based on a temporary analysis of 94 participants, divided between those given a placebo and those who were vaccinated, with Covid-19 disease. The trial will continue until 164 cases have occurred. If the data is held up and a critical safety result that Pfizer expects in about a week looks positive, it could mean the world has a key new tool to take control of. The pandemic has killed more than 1.2 million people worldwide.
As Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said: With the efficacy of the first vaccines previously predicted to be between 60% and 70%, the rate is more than 90% ” often”. Call with reporters.
Limited data. It is not known how well the shot method works in major subgroups, such as the elderly. William Gruber, Pfizer’s Senior Vice President of Vaccine Research and Development, said it was not yet known whether the vaccine would prevent serious illness, as none of the participants received Covid-19. in this analysis encountered such a case.
Outside researchers say they will need more data, including safety information, to gauge how good a vaccine is. Assuming encouraging early results are maintained and the vaccine is approved, community use remains a shortcut, with those at greatest risk going to be vaccinated 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 provides evidence of the concept that it is possible to make Covid-19 vaccine for humans.”
The vaccine is being tested on a two-dose regimen. The trial started in July, and since most participants have only received a second dose much more recently, no one knows how long the protective therapy will last.
However, noteworthy results range from the first large-scale trial to a good beacon effect for other test vaccines, especially the one developed by Moderna Inc. using similar technology. Its large trial can produce effective and safe results in a matter of weeks. If that study is also successful, there may be two vaccines available in the US by the end of the year.
Pfizer is expected to get two months of safety tracking data, a key metric that US regulators require prior to emergency licensing, by the third week of November. no problem currently, Pfizer may apply for a license in the US this month. A rotating assessment is underway in Europe.
So far, the trial’s data monitoring committee has identified no serious safety concerns, Pfizer and BioNTech said.
Lead the race
The positive preliminary data means the US pharmaceutical giant and its German counterpart are on track to be the first to use the vaccine, after signing prior agreements with governments around the world. gender gives hundreds of thousands of doses. The companies say they will be able to produce 1.3 billion doses – enough to vaccinate 650 million people – by the end of 2021. About 50 million doses are expected to be available by 2020.
“It shows that Covid-19 can be controlled,” BioNTech CEO Ugur Sahin said in an interview. “At the end of the day, it was a real victory for science.”
Pfizer has been caught up in a controversial political debate over how quickly US regulators should allow Americans to vaccinate. President Donald Trump has pushed for a decision to be passed before Election Day, but the regulators have put in place rigorous standards that make that goal largely out of reach.
On October 16, Pfizer CEO Albert Bourla said companies could get emergency use permission from U.S. regulators by the end of November if the test results show that the shoot is safe. and efficiency.
Donald Trump Jr. and Senator Ted Cruz questioned that the data was released on Monday, following the election. “Why now?” the senator asked, with the president’s son calling the timing “pretty awesome.”
Pfizer and BioNTech have a $ 2 billion deal to provide 100 million doses of the drug to the US, with the option to add 500 million. Among the pioneering projects, theirs is the only vaccine project that does not use White House-led Warp Speed funding to promote research, development or production. However, BioNTech received up to 375 million euros ($ 445 million) in development funding from the German government.
This firing is based on information RNA technology that has never been used in an approved drug. Using mRNA, which essentially teaches the body’s cells to become vaccine factories, allows it to be developed much faster than traditional vaccines.
Pfizer originally intended to conduct an analysis of the first test data after only 32 virus cases occurred in the trial, which attracted 43,538 volunteers in multiple countries. Analysis of the initial data has caused controversy among medical professionals. Other companies that are working on vaccines plan to wait longer before carefully reviewing the test information.
After discussions with U.S. regulators, Pfizer and BioNTech said they recently decided to drop the 32-case threshold and conduct the first analysis at a minimum of 62 cases. The review focused on Covid-19 infections over symtomatic, not just those with positive results.
While Pfizer was conducting those talks, they halted testing participants’ virus samples, Gruber said. By the time Pfizer made changes to the test plan and restarted the virus testing process a few days ago, about 94 cases had occurred, more than the level of testing needed to meet the new threshold.
Pfizer is racing to verify the data, which is still obscure for almost everyone at the company besides 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 council then got Gruber, Sahin, and other company representatives on the call and told them the vaccine had easily hit its mark of effectiveness.
“Everyone was pretty ecstatic,” Gruber said.
(Updated with Fauci’s comment in paragraph five)
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