Pfizer and BioNTech are starting a large study of a vaccine candidate for Covid-19 aimed at securing approvals — but it’s not the one for which results were released earlier this month.
The companies always said that they planned to pick from among four different candidates, all of which use a technology called messenger RNA to produce a protein on SARS-CoV-2, the virus that causes Covid-19. The vaccine is designed to lead the immune system to recognize the protein, and, it is hoped, to attack the virus.
On July 1, the companies announced results in a preprint publication showing that one vaccine candidate, BNT162b1, prompted an immune response in patients. That vaccine encoded a key portion of the spike protein, which SARS-CoV-2 uses to enter cells. The vaccine being taken forward, BNT162b2, encodes an optimized version of the whole spike protein, which should lead to “more consistent responses across diverse populations and in older adults,” Pfizer said in a statement.
Philip Dormitzer, a Pfizer vice president in charge of vaccines, said the selected vaccine appears to generate a stronger response, in part because it includes more of the spike protein. That could mean less variability in how people respond to the vaccine. It also seemed to cause fewer side effects. “It just seemed a bit milder,” Dormitzer said in an interview. “There were fewer reactions to immunization, and that was an important mark in its favor.”
Why this vaccine candidate would have milder side effects is not clear, but Pfizer scientists speculate it is because of changes made to the messenger RNA that make it easier for mammalian cells to produce it. Whatever the reason, Dormitzer said, this is the candidate Pfizer is testing during the pandemic, though it can’t rule out that other variants might be taken off the shelf in the future. “This really is the final choice,” he said.
The study, which began today, will recruit about 30,000 healthy volunteers between 18 and 85, randomizing half to get the vaccine and the rest to get placebo. Pfizer will recruit from about 120 sites in countries around the world, including the U.S., Germany, and Brazil. The primary goal is preventing patients from developing Covid-19, and the secondary endpoints include preventing severe cases of the disease and protecting volunteers against asymptomatic infections.
The announcement came hours after Moderna began a 30,000-participant trial of its own. Like Pfizer and BioNTech, Moderna’s vaccine uses messenger RNA to compel the body to produce spike proteins, leading to an immune response that will ideally protect subjects from Covid-19.
Pfizer and BioNTech said that they are on track to file for regulatory review as early as October, and that they plan to supply up to 100 million doses by the end of 2020 and 1.3 billion doses by the end of 2021.
Hey Matthew and Damian – are you getting bribes from Pfizer or BioNTech? If you really are journalists, then why are you not slinging the same mud as with your criticism on lack of data from Inovio and Moderna ????
If it is true that numerous, periodic immunizations will be required, the winning companies will make their early investors rich IMO.
I do not trust studies for people before animals are tested. Animals need studied first. The RHA vaccine delivery is a whole new approach to the way a vaccine is designed to work. It changes our DNA! Test animals first, people second with honest reporting. Please, this is vital.
BNTX is the real deal. They will land the cure sooner than later
how does this happen? where are the animal studies, the PI, PII. They are going to take a new vaccine right to PIII for 30,000. Or did I miss something..
Phases 1 and 2 were completed earlier this month.
Mr. T, “One would think . . .?” I don’t leap to judgement based on guesses. Perhaps Pfizer/BioNTech is acting on today’s Moderna announcement, so as to avoid looking like they are behind in the race. Or perhaps it’s something else unknown outside the company. But I certainly don’t hold it against them to be conservative on releasing data prematurely.
Mr. T, the press release was only about an hour ago. You can hardly expect a full release of data quite this soon. Moderna made their press release months before releasing their data.
Both BNT162b1 and BNT162b2 vaccines were studied in the same phase 1/2 trial NCT04368728 . Results for BNT162b1 were published 3 weeks ago. One would think that Pfizer would also have results for BNT162b2 from this same study available and published at the same time.
I find it interesting that you were all up in arms criticizing Moderna and Inovio for not releasing enough detailed information on their vaccine candidate. And here you are silent while Pfizer has released basically nothing on their vaccine candidate that is being advanced to phase 3 …