- German drugmaker BioNTech and partner Pfizer have picked a coronavirus vaccine candidate to advance into late-stage testing, beginning on Monday a large-scale clinical trial. They are the second group to do this week, following U.S. frontrunner Moderna.
- Unlike Moderna, BioNTech and Pfizer initially tested in humans four versions of their vaccine candidate. The two companies claim the version they chose for Phase 3 study was better tolerated than the one they advanced first, and potentially more effective in protecting older people at higher risk of COVID-19.
- If the trial succeeds, the two companies said they could seek an emergency use authorization "or some other form of regulatory approval" as early as October. The U.S. recently agreed to pay just under $2 billion to secure supply of 100 million doses of the vaccine, should it become available.
It's not a surprise to see BioNTech and Pfizer quickly follow Moderna into a Phase 3 study. The rival drugmakers are both harnessing the same cutting-edge messenger RNA-based technology that can produce vaccines far faster than traditional methods. That has helped each of them move at an historic pace, creating, developing and advancing experimental vaccines into final testing in a matter of months.
More noteworthy, however, is that Pfizer and BioNTech haven't chosen the version of their vaccine that was the subject of data published on a pre-print server in July. Instead they've gone with another variant, dubbed BNT162b2, that was one of the three other versions they were developing.
Initial study data for BNT162b2 will be submitted to a peer-reviewed journal "in the near future," the companies said. At that time, the manuscript will be posted online.
"Though a clear possibility, this was somewhat of a surprise," wrote SVB Leerink analyst Geoffrey Porges, in a note on the drugmakers' choice of vaccine candidate.
Each of the four vaccine candidates BioNTech and Pfizer have been developing deliver genetic material into the body to produce parts of the coronavirus the immune system can learn to attack. But they each have subtle differences. BNT162b1, the candidate for which there is the most publicly disclosed human data, instructs cells to make a key part of the coronavirus's signature "spike" protein. BNT162b2, the vaccine the companies have selected, carries blueprints to make the whole thing.
That difference is a big reason why BioNTech and Pfizer made their decision. They believe generating immune responses against more parts of the spike protein may translate into "more consistent responses across diverse populations and in older adults."
In early tests, two shots, given three weeks apart, of the version BioNTech and Pfizer are advancing given to elderly adults — people between 65 and 85 years old — led to a response that appeared to be more potent than those seen in the blood samples of recovered COVID-19 patients. The finding is particularly noteworthy given the elderly, with weaker immune systems, are less likely than others to respond to a vaccine.
But it's unclear whether that result translates into protection from coronavirus disease. Messenger RNA technology has yet to produce an approved medicine, let alone a vaccine.
The two companies also claimed that BNT162b2 appears more tolerable, causing "generally" mild to moderate side effects like fever, fatigue and chills — and no serious adverse events — in about 120 healthy volunteers treated thus far. The immune responses generated by both vaccines appear comparable, leading to the generation of antibodies as well as white blood cell responses.
Like Moderna, Pfizer and BioNTech are recruiting around 30,000 volunteers between 18 and 85 age years old and plan to enroll a diverse group of participants — particularly within hot spots where there is "significant expected SARS-CoV-2 transmission" and communities and individuals "who have been the most impacted."
The trial is testing whether the vaccine can prevent COVID-19 in patients who either have, or haven't already been infected with SARS-CoV-2. Prevention of infection, or hospitalization with severe disease, are secondary measures. That could make for a broader label for use "in effectively all individuals above 18 years of age," wrote Porges. That would be critical for mass vaccination campaigns because it would "obviate the need" for people to be screened before getting a shot.
On a conference call with analysts on Tuesday, Pfizer CEO Albert Bourla said he expects the company to have a "majority" of patients enrolled by the end of August and to provide an interim look at data in either September or October.
The planned purchase by the U.S. of $2 billion worth of the vaccine implied a price of roughly $19.50 per shot, which Bourla said is a good "benchmark" for an order of that size.
Angela Hwang, the president of the company's biopharmaceuticals group, indicated that the company would adopt a two-staged pricing plan. For as long as the pandemic lasts, Pfizer plans to price the vaccine for "broad access." making sure the company can supply it to governments around the world. Afterwards, if the coronavirus becomes seasonal, and people need to get booster shots "to create or maintain global herd immunity," the company will use a "regular pricing approach," Hwang said.
Executives expect that the second stage would begin either in late 2021 or 2022.
Pfizer, separately, announced second quarter earnings, reporting an 11% decline in revenue compared to the same period in 2019. Pfizer said that was mostly due to sagging numbers for its consumer health business and the 2019 loss of patent protection for Lyrica. But the pharma did note that shelter-in-place policies impacted the rate of vaccinations and new prescriptions for certain of its products.