Vaccine stocks: FDA experts recommend adding Omicron to Covid boosters

Vaccine stocks diverged on Wednesday after a split Food and Drug Administration panel voted to recommend including an omicron-fighting component in updated Covid boosters this fall.

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The Advisory Committee on Vaccines and Related Biological Products voted 19-2 in support of omicron-targeted booster shots. This puts the FDA on track to approve updated vaccines in time for a potential seasonal Covid increase this fall.

But many questions remain. Pfizer (PFE), Modern (MRNA) and Novavax (NVAX) tested several boosters, including shots aimed at omicron alone and bivalent injections. The latter targets the omicron plus the ancestral tribe of Covid. Complicating matters, omicron has its own sub-variants.

On Tuesday, the Centers for Disease Control and Prevention said that two of these – known as BA4 and BA5 – make up a combined 52% of cases in the United States. Problematic, vaccine manufacturers have not had a chance to test vaccines targeting these omicron spin-offs. Their updated shot is aimed at the former BA1 cousin.

It is impossible to specify exactly which variant will be dominant this fall, said Dr. Peter Marks, director of the FDA’s Center for Biology Evaluation and Research, during the meeting.

“What we do today is work in a very challenging area because none of us have a crystal ball,” he said. “We try to use every ounce of what we can from predictive modeling and from the data we have that emerges to try to get ahead of a virus that has been very cunning. For something that is only nanometers large, it has been pretty damn cunning. “

Vaccine stocks tackle Omicron

In the pre-market trading on today’s stock market, vaccine shares were mixed. The Moderna share lost 1.8% and traded close to 139.70. Shares of Pfizer and its partner, BioNTech (BNTX), each advanced a fraction close to 50.70 and 140.40, respectively. Novavax shares fell 4.4% to close at 48.80.

The case is now going to the entire FDA. The agency is not bound by the panel’s recommendation, but often follows the advice. If successful at the FDA, the omicron vaccine case will go to the CDC.

Two panelists voted against recommending an omicron update – Drs. Paul Offit and Henry Bernstein. None of them gave any explanation after the vote. But before the vote, Bernstein noted that data is still limited for boosters targeting BA4 and BA5. And Offit said he was uncomfortable with the level of protection the omicron boosters have.

In recent tests, Pfizer said the omicron booster led to a 13.5-19.6-fold increase in antibodies capable of blocking omicron and its spinoffs. A bivalent vaccine – which could target omicron and the first strain – generated a 9.1-10.9-fold increase in antibodies, depending on the dosage. Vaccine shares rose a fraction higher on Monday after the booster news.

Novavax highlighted

Similarly, Moderna tested a bivalent vaccine that includes an omicron-fighting component. This resulted in a 5.4-fold increase in antibodies capable of handling BA4 and BA5 sub-variants of omicron.

In people previously infected with Covid, this led to a 6.3-fold increase. Officials currently expect that the specific sub-variants will soon dominate Covid cases in the United States

Novavax does not yet have authorization for a primary Covid series in the United States, but biotechnology is testing an omicron booster as well as a bivalent booster that contains an omicron-fighting 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 does not necessarily mean that boosters will be proposed for everyone by the fall. But the vote 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 image. The latter called Novavax’s results “the most compelling I’ve seen today.” He noted that Novavax’s prototype booster, given after eight months, protected against BA1, BA2 and BA5.

Marasco questioned the ultimate effectiveness of the messenger RNA vaccines. Novavax uses a protein-based technology.

“I wonder after seeing this data if we are not witnessing any of the limitations that mRNA vaccines may have,” he said. “Yes, they were first out of the gate. But they do not seem to be able to have that kind of protection. So really the question is whether we need to change the composition of the Covid vaccine strain? I think the answer will depend on what the vaccine is. “

Take care of the children

Another important piece for vaccine stocks: children. The FDA is only a week away from registering for primary shots for children under 5 years of age. There is little data in the pediatric population. That 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 that immune bridge building – a process that derives the effectiveness of a vaccine under different circumstances – would not be sufficient for children. Because boys and young men are susceptible to heart inflammation after vaccination, dose-response and safety studies should be completed in young children, he argued.

He worried that young children “are always behind the curve when it comes to getting vaccinated.”

Panelist Dr. Cody Meissner also suggested that repeated booster doses may eventually lead to increasing side effects. He suggested that the case could be particularly difficult for children.

A representative of Moderna said that the company expects to have updated data from its omicron shots – an injection focused exclusively on omicron and a bivalent containing an omicron-fighting component – in babies and young children in October or November. However, these shots are aimed at BA1, not the more dominant sub-variants BA4 and BA5.

Follow Allison Gatlin on Twitter at @IBD_AGatlin.

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