A separate Food and Drug Administration voted Tuesday to recommend the inclusion of an omicron-fighting component in updated Covid boosters this fall. But vaccine supplies collapsed.
The Vaccines and Related Biological Products Advisory Committee voted 19-2 in support of Omicron-targeted booster vaccines. This puts the FDA on track to approve updated vaccines in time for a possible fall seasonal Covid surge.
But many questions remain. Pfizer (PFE), modern (MRNA) and Novavax (NVAX) tested several boosters, including shots targeting Omicron alone and bivalent injections. The latter target Omicron and the ancestral tribe of Covid. To make matters worse, omicron has its own subvariants.
On Tuesday, the Centers for Disease Control and Prevention said two of these – known as BA4 and BA4 – together make up 52% of US cases. The problem is that vaccine makers haven’t had a chance to test vaccines targeting these Omicron spinoffs. Her updated shots target the former BA1 cousin.
It’s impossible to pinpoint exactly which variant will be dominant in the fall, said Dr. Peter Marks, director of the FDA Center for Biologics Evaluation and Research, during the meeting.
“What we’re doing today is working on a very challenging area because none of us have a crystal ball,” he said. “We’ve been trying to use every last ounce of what we can get out of predictive modeling and from the data we have to try and get ahead of a very clever virus. For someone only nanometers tall, it was pretty damn smart. “
Vaccine stocks attack Omicron
But in after-hours trading on today’s stock exchange, vaccine stocks were relatively muted, moving less than 1% either way. Stocks plummeted during the regular session.
Pfizer shares lost 2.4% to end the day at 50.66. shares of his partner, BioNTech (BNTX) fell 2.7% to 139.82. Moderna shares slipped 2.2% to 142.19. Novavax shares fell 5.1% to 51.06.
The matter now goes to the entire FDA. The agency is not bound by the panel’s recommendation, but often follows advice. If successful with the FDA, the matter with the Omicron vaccine will be escalated to the CDC.
Two panelists voted against recommending an omicron update. dr Paul Offit and Henry Bernstein. Neither offered an explanation after the vote. Before voting, however, Bernstein noted that data for boosters targeting BA4 and BA5 is still limited. And Offit said he was unhappy with the level of protection provided by the Omicron boosters.
In recent tests, Pfizer said its Omicron booster resulted in a 13.5- to 19.6-fold increase in antibodies able to block Omicron and its offshoots. A bivalent vaccine – which could target Omicron and the first strain – produced a 9.1- to 10.9-fold increase in antibodies, depending on the dose. Vaccine stocks rose a fraction Monday after the booster news.
Moderna tests bivalent vaccine
Similarly, Moderna tested a bivalent vaccine containing an Omicron-fighting component. This resulted in a 5.4-fold increase in antibodies capable of handling the omicron subvariants BA4 and BA5.
This resulted in a 6.3-fold increase in people previously infected with Covid. Officials currently expect that these specific subvariants will soon dominate Covid cases in the United States
Novavax has not yet been approved for a primary Covid series in the US. Despite this, the biotech is still testing an Omicron booster as well as a bivalent booster containing an Omicron combat component. When tested, both options resulted in “high” effectiveness, the company said in briefing documents.
dr Amanda Cohn, another panelist, said the recommendation doesn’t necessarily mean booster shots would be suggested for everyone in the fall. But voting is an important step towards authorization. Panelist Dr. Arthur Reingold made a similar statement.
“Who gets what and when?” he asked.
Panelist Dr. Wayne Marasco also questioned the ultimate efficacy of Pfizer’s and Moderna’s messenger RNA vaccines. Novavax’s Covid vaccine, on the other hand, uses a different technology based on proteins.
“We can do better and I’m not sure the mRNA vaccines will give us the best kind of immunity that we can get here,” he said during the discussion.
take care of the kids
Another key piece for the vaccine stockpile: children. The FDA is just a week away from releasing the primary vaccine for children under 5 years old. There are few data in the pediatric population. This fact is unacceptable, said panelist Dr. Archana Chatterjee.
“The pediatric studies need to be done, and they need to be done now,” she said.
Similarly, panelist Dr. Michael Nelson that immune bridging – a process that predicts the effectiveness of a vaccine in different circumstances – would not be enough for children. Because boys and young men are vulnerable to heart inflammation after vaccination, dose-response and safety studies should be conducted in young children, he argued.
He worried that young children “always fell behind the power curve when given vaccines.”
The panelist Dr. Cody Meissner also suggested that repeated booster doses could eventually lead to increasing side effects. He suggested that the matter could be particularly difficult with children.
A Moderna representative said the company expects updated data on its Omicron injections — an injection that focuses solely on Omicron and a bivalent that contains an Omicron-fighting component — in babies and toddlers in October or November. However, these shots target BA1, not the more dominant BA4 and BA5 subvariants.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
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