A group of advisers to the Food and Drug Administration is meeting Friday to discuss whether the agency should clear Johnson & Johnson's coronavirus vaccine for emergency use.
Results from a large international study of roughly 40,000 volunteers found the shot was 66% effective in preventing moderate or severe COVID-19, although protection appeared weaker against a virus variant first detected in South Africa. FDA scientists reviewing the vaccine affirmed J&J's findings in documents published Wednesday.
While a positive review is expected, the gathered vaccine and infectious disease experts will still have much to consider, including differences between J&J's vaccine and the two already available from Pfizer and Moderna. Meetings on each of those vaccines last December led to FDA authorizations, in both cases, the very next day.
BioPharma Dive will be tracking the meeting, which will be broadcast on YouTube beginning at 9:00 am ET, and reporting back here. Check back often as we update this page throughout the day.
Updated 11:10 am
For more vaccines to quickly get to market — or for the existing ones to become available to children and, eventually, infants — determining how much of an immune response is needed to confer protection is a critical step. Identifying these so-called correlates of protection would help developers predict whether their shots are effective and avoid lengthier trials.
Variants, however, appear to have made that objective more difficult, because each might require different levels of neutralization, Meissner said. "The threshold of immunity will probably vary depending on the vaccine, and depending on the variants that circulate," he said.
MacNeil, the CDC official, agreed. A correlate of protection is now "a moving target," he acknowledged.
"The fundamental question as the outbreak progresses is, how is this virus going to behave?" he asked. "Are we going to need annual updates, like influenza … or will we have broad enough protection to use, what's in essence, a steady-state vaccine?"
For their part, Moderna and Pfizer have already begun preparing for a worst-case scenario by readying boosters or modified shots. J&J hasn't yet disclosed its plans. — Ben Fidler
10:30 am
Adam MacNeil, a deputy director within the CDC's immunization safety office, outlined what the agency refers to as "variants of concern." They are evolved versions of the coronavirus that have shown evidence of an impact on drugs or diagnostics; increased transmissibility or disease severity; and the potential to evade an immune response triggered by previous infection or vaccination.
The three variants of concern so far are well-known: B.1.1.7, first detected in the U.K.; B.1.351, which originated in South Africa; and P.1, which was first found in Brazil. B.1.1.7 is more transmissible than the original virus, while B.1.351 has a mutation to the coronavirus's spike protein that appears to reduce vaccine potency. P.1 has the same alteration, but hasn't been proven yet to affect vaccines.
MacNeil said the CDC is conducting surveillance and investigation of variants in the U.S., looking in particular for vaccine "breakthroughs," when infections occur despite immunization. The agency has seen roughly 1,600 cases caused by B.1.1.7; 22 cases of B.1.351; and 5 of P.1.
B.1.1.7 is expected to become the "dominant" strain in mid- to late-March, MacNeil said. But because it doesn't appear to affect vaccine potency, its impact could be substantially blunted by an aggressive uptick in vaccinations. — Ben Fidler
10:20 am
Since the advisory committee last met to vote on Moderna's vaccine, concerns over coronavirus variants have become much more acute. In particular, the B.1.351 variant, first identified in South Africa, has been shown to limit the potency of several vaccines, weakening the immune response to Moderna's and resulting in lower efficacy in Johnson & Johnson's trial sites in South Africa.
Committee member Cody Meissner, a pediatric infectious diseases physician at Tufts Medical Center, asked if the FDA had considered changing trial endpoints to account for the new variants.
Maria Allende, chief of the FDA unit in charge of J&J's application, said the current endpoint, which compares COVID-19 incidence in vaccinated volunteers against unvaccinated people, remains the best measure. Clinical trial investigators don't have other options until scientists can establish a clear biological measure that can predict whether a vaccine will protect against disease, Allende said.
However, she added the FDA is working on new measures. "We are engaged in several conversations to implement strategies to monitor and address the issue of variants that are circulating," Allende told committee members. — Jonathan Gardner
9:53 am
Maria Allende, a branch chief within the FDA's vaccine review division, began the meeting with a sobering statistic. Though COVID-19 cases, hospitalizations and deaths have all declined substantially, there were still over 400,000 cases in the U.S. over the week ending Feb. 24 and more than 2,000 deaths each day.
Those numbers are the lowest the U.S. has reported for months. But they're also far higher than what was reported for most of last year. It's a reminder of the urgent need for another vaccine, as well as for continued mitigation strategies. — Ben Fidler
9:00 am
Arnold Monto, an epidemiologist and professor at the University of Michigan, opened the meeting as chair of the 22-member advisory committee that will be reviewing J&J's vaccine today.
Most of the committee members are the same as those who reviewed Pfizer's and Moderna's vaccine in December. But there are a few changes. Sheldon Toubman, a Connecticut lawyer and consumer representative in past meetings, has been replaced by Jay Portnoy, a University of Missouri professor and allergist at Children's Mercy Hospital in Kansas City. Two other members from the Dec. 17 meeting on Moderna's vaccine have also been replaced.
In the morning, the FDA will review its emergency use authorization framework, while a CDC official will give an update on the epidemiology of new coronavirus variants. Another official, Tom Shimabukuro, will discuss safety data that's been collected since immunizations with Pfizer's and Moderna's vaccines began.
J&J will present just before lunch, which will be followed by an open public hearing and the FDA's presentation. Much of both presentations will go over documents released on Wednesday.
The most important part of the meeting comes at 3:10 pm ET, when the committee will begin its debate over whether to recommend use of J&J's shot. Panel members to watch include Archana Chatterjee, Michael Kurilla, A. Oveta Fuller and H. Cody Meissner, all of whom were more vocal in raising concerns and questions during the December votes on Pfizer's and Moderna's vaccines. — Ned Pagliarulo
J&J's shot uses a virus to shuttle a DNA sequence for the coronavirus's spike protein into the body, while Moderna's and Pfizer's rely on tiny lipid bubbles carrying messenger RNA. J&J's is given as a single dose, rather than a two-dose regimen. It's also easier to store and ship than the others.
All three offer near-complete protection against severe COVID-19, hospitalization or death — a significant finding now reported for several vaccines.
Beyond that result, it's harder to compare J&J's vaccine directly to the others. Moderna's and Pfizer's shots were nearly 95% effective at preventing COVID-19, but those results came late last year and were recorded before the spread of new variants that appear to weaken vaccine potency.
J&J's shot was 66% effective, but it was tested later and performed worse against the so-called B.1.351 variant, which originated in South Africa and has since spread to other countries, including the U.S. Testing also hasn't gone on long enough to determine whether one shot offers long-lasting protection.
What's more, J&J counted COVID-19 cases slightly differently than Moderna and Pfizer, adding a wrinkle to any direct comparison. — Ben Fidler
The FDA is widely expected to authorize J&J's vaccine soon after the meeting, potentially making the day's discussion less dramatic. But the virtual gathering is nonetheless a critical forum to discuss emerging pandemic issues, most notably coronavirus variants and how to combat them.
One high-ranking official from the Centers for Disease Control and Prevention will give a briefing later today on the variants that have recently spread across the globe. That discussion will come after a week in which the FDA released guidelines for updating vaccines to address new viral strains, and Moderna and Pfizer both progressed plans to test boosters or modified shots.
Experts will also get the most detailed look to date at the impact of the B.1.351 variant. J&J has the most efficacy data against B.1.351 of any vaccine developer, and its shot's protection against COVID-19 was clearly diminished by the variant. The vaccine seemed to still protect volunteers against severe disease comparably well regardless of variant, however. — Ben Fidler
Distribution of the two available coronavirus vaccines has ramped up considerably after a slow start, with some 46 million Americans, or about 14% of the population, having received at least one dose as of Wednesday, according to data from the Centers for Disease Control and Prevention. But supply remains a bottleneck, as most of the doses the U.S. preordered from Moderna and Pfizer won't be delivered until between April and July.
The imminent authorization of J&J's shot will help, though as with Moderna and Pfizer, only a fraction of the 100 million doses the U.S. ordered will be available right away. A J&J executive testifying before Congress this week said the company could deliver roughly 4 million doses upon FDA clearance, and 20 million by the end of March. J&J has promised to ship all 100 million doses by the end of June. — Ben Fidler