2022 forecast: With omicron extending the pandemic, how will biopharma respond to COVID?

Think back to this time last year. Remember the uncertainty the COVID-19 pandemic posed?

Well, thanks to omicron, here we are again, asking many of the same questions and with renewed anxiety about the future.

At least now we know the drill. “I see COVID continuing to have new variants and coming back each season,” Cantor Fitzgerald’s Grace Chen told Fierce Pharma.

We also know what questions to ask. Is omicron more contagious? Will vaccines and treatments be effective? Are we destined for a return of restrictions and lockdowns? And, after omicron, what’s next? Are we simply on a coronavirus hamster wheel, with many more variants yet to contend with?

As the pharmaceutical industry approaches 2022, there is some comfort knowing that a blueprint is in place to respond to the pandemic—and one that will allow business to continue. But what about those best-laid plans based on the belief that the pandemic would transition into an endemic in 2022?

“If we look at the global situation, I think it’s fair to say that we are still in very challenging times,” Rasmus Bech Hansen, CEO of Airfinity, a life sciences analytics company, said during a recent press briefing. “Cases globally are rising quite significantly. We are sadly not far from the biggest peak we had in 2021.”  

Vaccine makers respond to omicron

For pharma companies, the scramble is back on to find drugs that can prevent and treat omicron. COVID-19 vaccine producers such as Pfizer-BioNTech and Moderna have ramped up their efforts to create an omicron-tailored shot. And they are in an optimal position to do so quickly and efficiently, as they have the mRNA expertise.

“We continue with high speed with the development of a potential omicron vaccine to be ready if one is needed,” BioNTech CEO Ugur Sahin, said earlier this month in a press conference.

The companies have said it would be possible to have an omicron-adapted vaccine ready by February or March. Airfinity estimates that it would take until September for a different company with a new omicron-adapted vaccine to receive approval.  

“This is the highest level of alert we’ve ever been on, by far,” Moderna President Stephen Hoge, M.D., told The Washington Post.

If an omicron-adapted vaccine is required, scaling up to manufacture it will slow the pace of production. Airfinity’s current projection for 2022 global vaccine production is 8.7 billion doses. But if a new shot is needed, the analytics group figures only 5 billion doses will be manufactured, with some producers leaving the market entirely as demand for their shots disappears.

“We are already freeing up capacity for plasmid production,” Sierk Poetting, BioNTech’s chief operating officer, said in the press conference. “The production process itself, once you have the plasmid, is exactly the same.” 

RELATED: Pfizer, Moderna, J&J and AstraZeneca assess omicron's effect on their COVID-19 vaccines   

The emergence of omicron will keep many more companies busy than the handful that have developed successful vaccines and antibodies. There are 358 COVID-19 vaccines in preclinical development around the world, says Airfinity. And of the 175 candidates in clinical development, 41 are in phase 3.

Among those in development are combination vaccines that would inoculate against COVID-19, the flu and other respiratory diseases. Also in the works are different forms of vaccines that might gain acceptance with those who are hesitant.   

“There’s no doubt that needle injections are keeping some people from being vaccinated, so we are seeing intranasal, we’re seeing oral, we’re seeing needle-free injection,” Bech Hansen said in the press briefing. “Looking into 2022, we can expect significant innovations and scientific progress as we have already witnessed in 2021.”

The emergence of omicron has been a wake-up call that COVID-19 will remain a major threat for a while. For example, it recently compelled analysts at Cantor Fitzgerald to increase their projection of 2027 sales for the Pfizer vaccine, Comirnaty, from $10 billion to $25 billion.    

But while omicron presents a new challenge, it’s not as though vaccine makers are starting at square one. Michelle McMurry-Heath, CEO of the Biotechnology Innovation Organization, remembers the “daunting” feeling the pandemic brought a year and a half ago. 

“We set out to decouple infection from death and disability, and we are starting to see quite a bit of that decoupling, and that is incredibly promising,” McMurry-Heath said. “In the U.S. alone, mRNA vaccines have saved more than a million lives in this last year. Can you think of another medical innovation that within its first year of use saved a million lives? It’s absolutely miraculous.”

Other COVID-19 treatments

With omicron’s emergence, the scramble also is on to uncover drugs to treat those who are infected with COVID-19. In lab studies, the most commonly used treatments, antibodies by Regeneron and Eli Lilly, show little effectiveness against omicron.

Another approved antibody treatment, produced by GlaxoSmithKline and Vir Biotechnology, is the best available option against omicron, but supply is quickly becoming strained.

RELATED: GlaxoSmithKline and Vir's sotrovimab stands up to omicron despite other COVID antibodies falling short

Meanwhile, Regeneron and Lilly are busily developing treatments to address the new variant. Regeneron CEO Len Schleifer, M.D., Ph.D., said the company could be ready with their adjusted version in the first quarter of 2022, and it will be effective against multiple variants.

“We need to figure out a way to get this to patients on a large scale before the next variant shows up. We don’t want to be chasing our tail here,” Schleifer told CNBC.

“We have a whole host of new antibodies which can work against both omicron and delta.”

Another option coming is Pfizer’s oral antiviral Paxlovid, which had yet to be approved as of Dec. 21. Considering that a trial has shown Paxlovid cuts the risk of hospitalization and death by 89% and the demand it is likely to generate, it could also face supply problems initially.

Merck and Ridgeback's oral antiviral molnupiravir hasn't fared as well in testing. After an interim trial result showed it cut the risk of hospitalization and death by 50%, more complete data later showed a risk reduction of 30%.  

While the biopharma—and virtually every other—industry initially recoiled with the market uncertainty and restrictions brought on by the pandemic, those factors receded through 2021. Will the emergence omicron bring a return to those factors?

Glenn Hunzinger, leader of the U.S. pharma and life science segment at business consulting firm PwC, doesn’t think so.

“We believe that we’re past the concerns of COVID stopping the business environment,” Hunzinger told Fierce Pharma. “Ultimately people have figured out a way to do business. I think this is just the new norm of how the world will operate.”