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Pfizer said Wednesday that new test results show its coronavirus vaccine is 95 percent effective, safe, and also protects older people at higher risk of death – the latest data needed to find the use of limited vaccine supplies emerge as the catastrophic outbreak worsens around the world.
The announcement by Pfizer and its German partner BioNTech, just a week after they revealed the first promising preliminary results, comes as the team prepares within days to formally petition US regulators to allow emergency use of the vaccine. In anticipation of that, an advisory panel from the Food and Drug Administration is on standby to publicly debate the data in early December.
The companies have also started making “rolling submissions” for the vaccine with regulators in Europe, the UK and Canada and will add this new data soon.
Pfizer and BioNTech had initially estimated the vaccine to be more than 90 percent effective after counting a group of the first infections that occurred in its final testing stage. With the new announcement, they have racked up more infections (170) and said only eight of them occurred in volunteers who received the actual vaccine rather than a sham comparison injection. One of those eight developed a serious illness, the companies said.
“This is extraordinarily strong protection,” Dr. Ugur Sahin, CEO and co-founder of BioNTech, told the Associated Press.
Even if regulators agree, he dispelled any notions that the end of the pandemic is just around the corner, warning that “we are now expecting a harsh winter.”
“The vaccine doses available are too small to guarantee that we can make a significant difference in society” right away, Sahin said. But next year, if the candidate vaccines from several companies also work, “we could get this pandemic under control by late summer 2021.”
The companies have yet to release detailed data on their study and independent experts have not analyzed the results. Important questions such as how long protection lasts and whether people might need backups also remain to be determined, leading experts to caution that people should focus less on specific numbers and more on the overall promise.
Earlier this week, competitor Moderna Inc. also announced similar effectiveness of its own Covid-19 candidate vaccine, which is made with the same new technology, using a snippet of the coronavirus genetic code to train the body to recognize if it appears. the real virus.
For both, “there are many reasons to be hugely optimistic,” said Dr. Paul Offit of the Children’s Hospital of Philadelphia, one of the FDA’s advisers.
“When these vaccines are released, you will only know that it is effective for a limited period of time,” he warned, adding that more follow-up information will come. “You don’t want to oversell it, but you don’t want to sell it less.”
All eyes are on the progress of potential vaccines as the number of infections increases in the US and abroad as winter weather forces people to stay indoors, in enclosed spaces that they fuel viral spread.
Pfizer and BioNTech said the vaccine was more than 94 percent effective in adults 65 and older, although it is unclear exactly how it was determined with only eight infections in the vaccinated group to test and no breakdown of the ages of those was provided. people.
Sahin said there were enough older adults enrolled in the study and among the placebo recipients who became infected, he is confident that “this vaccine appears to work in the highest-risk population.”
While initial supplies will be scarce and rationed, as supply increases, Sahin said companies have a responsibility to help ensure access to lower-income countries as well.
In the US, officials are hoping for enough doses of the Pfizer and Moderna vaccines to vaccinate only about 20 million people initially. The Centers for Disease Control and Prevention will determine who is first in line, and is expected to include healthcare workers and older adults.
Whatever that prioritization, Gen. Gustave Perna of the Trump administration’s Operation Warp Speed promised a “fair and equitable” distribution in the United States of FDA-cleared doses as they become available. Pfizer would take care of shipping its own doses; The Warp Speed program will assist with vaccine distribution and support from additional companies when available.
In addition to the protective findings, Pfizer and BioNTech also said that no serious side effects have been reported from the vaccine, and that the most common problem is fatigue after the second dose of the vaccine, which affects approximately 4 percent of participants.
The study has enrolled nearly 44,000 people in the United States and five other countries. The trial will continue to collect safety and efficacy data on volunteers for a further two years.
Pfizer and BioNTech said they expect to produce up to 50 million doses of vaccines globally in 2020 and up to 1.3 billion doses in 2021. AP
