Vaccine stocks jumped on Wednesday after a split Food and Drug Administration panel voted to recommend the inclusion of an omicron-fighting component in updated Covid boosters this fall.
The Vaccines and Related Biologicals Advisory Committee voted 19 to 2 in favor of omicron-targeted booster shots. This puts the FDA on track to authorize updated vaccines in time for a possible seasonal Covid surge in the fall.
But many questions remain. Pfizer (EFP), Modern (ARNM) and Novavax (NVAX) tested several boosters, including injections targeting omicron alone and bivalent injections. The latter targets the omicron plus the ancestral strain of Covid. To complicate matters, omicron has its own sub-variants.
On Tuesday, the Centers for Disease Control and Prevention said two of them – known as BA4 and BA5 – account for a total of 52% of cases in the United States. Problem is, vaccine makers haven’t had a chance to test vaccines targeting these omicron fallouts. Their updated shots target the old BA1 cousin.
It’s impossible to determine exactly which variant will be dominant in the fall, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said at the meeting.
“What we’re doing today is working on a very difficult area because none of us have a crystal ball,” he said. “We’re trying to use every last ounce of what we can of predictive modeling and data that we have that’s emerging to try to get ahead of a virus that’s been very crafty. For something that’s only nanometers in size , that was damn tricky.”
Vaccine stocks attack Omicron
In early trading in today’s stock market, vaccine stocks rose slightly. Shares of Moderna, Pfizer and BioNTech (BNTX) were up less than 1% each. BioNTech is Pfizer’s partner on the Covid vaccine. Novavax shares jumped 1.3% near 51.70.
The case now goes to the whole of the FDA. The agency is not bound by the panel’s recommendation, but it often follows the advice. If successful at the FDA, the omicron vaccine issue will go to the CDC.
Two panelists voted against recommending an omicron update – Drs. Paul Offit and Henry Bernstein. Neither provided an explanation after the vote. However, before the vote, Bernstein noted that data is still limited for boosters targeting BA4 and BA5. And Offit said he was not comfortable with the level of protection Omicron boosters have.
In recent tests, Pfizer said its omicron booster resulted in a 13.5- to 19.6-fold increase in antibodies capable of blocking omicron and its fallout. A bivalent vaccine – which could target the omicron and the first strain – generated a 9.1 to 10.9-fold increase in antibodies, depending on the assay. Vaccine stock rose slightly on Monday after its recall news.
Similarly, Moderna has tested a bivalent vaccine that includes an anti-omicron component. This resulted in a 5.4-fold increase in antibodies capable of handling the BA4 and BA5 subvariants of omicron.
In people previously infected with Covid, this led to a 6.3-fold increase. Officials currently expect these specific subvariants to soon dominate US Covid cases.
Novavax does not yet have clearance for a first Covid series in the United States. But biotech is testing an omicron booster as well as a bivalent booster containing an anti-omicron component. In testing, both options led to “high levels” of efficiency, the company said in briefing documents.
Dr. Amanda Cohn, another panelist, said the recommendation doesn’t necessarily mean boosters will be suggested for everyone in the fall. But voting is an important step towards authorization. Panelist Dr Arthur Reingold made a similar assessment.
“Who gets what and when? ” He asked.
Drs. Wayne Marasco and James Hildreth, both panelists, were particularly impressed with Novavax’s Covid hit. He called Novavax’s results “the most compelling thing I’ve seen today.” He noted the Novavax booster prototype, given at eight months, protected against BA1, BA2 and BA5.
Marasco questioned the ultimate efficacy of messenger RNA vaccines. Novavax uses protein-based technology.
“I wonder after seeing these data if we are not witnessing some of the limitations that mRNA vaccines may have,” he said. “Yes, they were the first to come out. But they don’t seem to be able to have that kind of protection. So really the question is do we have to change the composition of the Covid vaccine strain? I think that the answer would depend on what the vaccine is.”
Take care of children
Another important piece for vaccine stocks: children. The FDA is only a week away from approving primary injections for children under 5. 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 said immuno-bypass – a process that infers the effectiveness of a vaccine under different circumstances – would not be sufficient for children. Since boys and young men are susceptible to cardiac inflammation after vaccination, dose-response and safety studies should be done in young children, he argued.
He was concerned that young children “are always behind the power curve for receiving vaccines”.
Panelist Dr. Cody Meissner also suggested that repeated booster doses could ultimately lead to increased side effects. He suggested the issue could be particularly tricky in children.
A Moderna representative said the company expects to have updated data on its omicron injections — an injection focused solely on omicron and a bivalent containing an omicron-fighting component — in babies and babies. young children in October or November. However, these shots target BA1, not the more dominant BA4 and BA5 sub-variants.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
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