The Covid-19 vaccine market is crowded — as demand begins to decline

CUrevac, a pioneer in its efforts to use messenger RNA as a vaccine platform, and its partner, pharmaceutical giant GSK, saw a sentence on the wall last fall.

The pair changed plans when CureVac’s Covid-19 mRNA vaccine candidate was overwhelmed in the Phase 2b / 3 trial. Too many other vaccines have already proven to be superior and have been approved by regulatory agencies. Instead of spending months fine-tuning candidates who will be competing for a rapidly shrinking share of the Covid vaccine market, they will instead focus on second-generation products.

Soon, experts tell STAT that other Covid vaccine makers are ready to face the same kind of harsh reality. Two new players from the Novavax and Sanofi-GSK partnerships have entered or are about to enter the already crowded global Covid vaccine market, and are still struggling to prove that their vaccines are protective. The outlook for those who are is getting slimmer.

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The shrinking demand does not help.

“There seems to be a long-term, ongoing demand for Covid vaccines, at least for boosters,” said Airfinity, a London-based health analysis company that closely tracks the development and regulation of Covid vaccines. Analysis Director Matt Linley said. Sales and usage. “But it’s much smaller than it really is. I think it’s like it’s peaked.”

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Today, the world can produce and administer more Covid vaccines than it needs — more than 12 billion doses per year. For many existing manufacturers, purchases have peaked.Some players already Reduction of production.. Experts want to enter the market with yet another vaccine that targets the original SARS-CoV-2 strain or does not offer advantages over existing products, to find a buyer I warned that I would have a hard time.

According to experts, demand for new vaccines (products that are not as difficult to use as mRNA vaccines) is modest or stagnant. Even in countries where the use of mRNA vaccines is not practical, they are considered the gold standard. Can the recombinant protein vaccines produced by Novavax and Sanofi-GSK break through? Unclear, Linley suggested. “I think there was a lot of hype around Novavax, but in reality, we only know the time.”

The virus, on the other hand, raises the bar that latecomers must hurdle to show that the vaccine is defensive.

Early market entrants Pfizer / BioNTech, Moderna, AstraZeneca, Johnson & Johnson, Russian Sputnik V, and multiple Chinese vaccines were the only way to get vaccinated was to volunteer for research. Occasionally we conducted clinical trials. Finding a unicorn may be easier than finding people who have not been vaccinated and are willing to participate in the Covid vaccine trial.

The company that developed the early vaccines conducted the test before the arrival of a series of mutants with mutations that helped avoid Covid inoculation and immunity induced by previous infections. The Pfizer vaccine was initially staggering 95% effective and would not have been so impressive if clinical trials were conducted during the Omicron era. Testing now a first-generation Covid vaccine designed to protect against the original gene sequence of the virus shared in January 2020 publishes a wanted poster for his great-grandfather, not the suspect. It’s like doing.

Moreover, the urgency to speed up the use of vaccines that have penetrated regulatory and political conditions in the fall of 2020 is no longer important. The Food and Drug Administration and other regulators have recently processed emergency approvals in less rapid turnarounds. There is a sufficient supply of other options.

All of this poses a major challenge for companies still working on the Covid vaccine, reducing the opportunity for all companies to record the sales they seek.

That doesn’t mean there are no opportunities at all. Experts agree that there is still a better vaccine market.

Michael Osterholm, director of the Center for Infectious Diseases Research Policy at the University of Minnesota, said: “These are very important temporary measures now, but what we need in the future will be significant improvements to previous versions.”

They include vaccines that reduce SARS-CoV-2 virus infection, perhaps through intranasal delivery, by protecting against even mild infections. There is also room for long-lasting vaccines on the market and vaccines that provide greater protection from the various forms that the SARS-2 virus can invade. In other words, it is a vaccine that is not very vulnerable to the emergence of variants. There is also room for vaccines that can protect against multiple coronaviruses, thereby reducing the risk of future coronavirus pandemics.

“I think finding a way to look to the future is the next big challenge for the world,” said Phil Krause, deputy director of the FDA’s Vaccine Department. Suddenly ends last year. Krause is currently a consultant and frequently works with the World Health Organization. (He has not consulted with industry clients about the Covid vaccine.)

Norman Baylor, the former director of the FDA’s Vaccine Department, agreed to the need for a better vaccine, but warned that it would not be easy to launch a new product in this crowded area. And the fast-paced regulatory path in the United States (the FDA’s Emergency Use Authorization) is unlikely to be an option for much longer, he said.

“I think the door is closed,” said Baylor, a member of the Scientific Advisory Group of Valneva, a French company that currently runs Biologics Consulting and manufactures CureVac and inactivated Covid vaccines. “Just looking at the regulation, there are a lot of vaccines, so the regulation should end.”

According to WHO Covid vaccine trackerThere are 149 candidate vaccines in clinical development, tested in people, and an additional 195 in the early stages of testing. In addition, at least 21 vaccines have been approved or approved for use worldwide, some in multiple countries and others only in the domestic market.

According to Baylor, this type of research is not sustainable. Countries like the United States, which have invested billions of dollars in vaccine development through Operation Warp Speed, are tightening their purses.

“Remember, big players, they were subsidized by the government. That subsidy will be exhausted,” Baylor said. “And now they will have to go to venture capitalists, and the venture capitalists say,” Um, another Covid vaccine? Why?'”

Why is that so?

In an interview, Airfinity’s Linley said sales were flat and production was declining for most of the existing manufacturers.

We peaked at a dose of about 1.4 billion times [per month] It is in production, “he said. “It was around November, and now we are producing about 800 million doses a month.”

The exception to this trend is the mRNA vaccine manufactured by Pfizer and Moderna. These vaccines appear to be less effective than other competitors, but they continue to outperform the market.

“They are the only vaccines that consistently make new deals and new agreements to sell vaccines. Only Pfizer and Moderna,” Linley said.

Affinity modeling suggests that even in the most optimistic scenario (countries vaccine 80% of the population and then boost once or twice a year), the Covid vaccine market will shrink.

In many countries, you can’t get close to that 80% figure. By the way, in the United States, the proportion of people eligible for vaccination, that is, those who have completed the primary series, out of the population over 5 years old, has been around 70% for quite some time. (And only 46% of qualified boosters received it. Baylor, for example, doesn’t believe a regular booster would find an avid recipient. Tired, “he says. rice field.)

WHO has set a 70% vaccination target in all countries by June, but Seth Berkley, CEO of the vaccine alliance Gavi, said that many countries have all the elements of their vaccination program (in vaccines). Plus enough) said it would take longer to implement. In addition to trained vaccinations, supplementary supplies such as mRNA vaccines and cold chains for suitable syringes — to hit that number. Some people don’t even try to reach 70%. He said many countries have set more modest goals for themselves.

“I don’t think many countries will be able to meet these goals,” Berkeley said, adding that it could change if new mutants that cause more severe illness emerge. If that happens, he said the supply-demand equation could be reversed.

Future demand can be determined by two factors. It is the pathway of future variants and how long protection against serious illness will last. When new variants emerge that circumvent the ability of vaccines to prevent hospitalization and death, countries will buy the latest vaccines. Similarly, if immunization from vaccination or previous infection no longer prevents serious illness, the government orders booster immunity. When these scenarios occur, some people roll up their sleeves again.

Manufacturers obviously want to sell booster shots every year. Pfizer is already seeking approval for additional boosters for people over the age of 65. And Moderna last week announced that it would ask the FDA for permission to provide boosters to all adults. However, the jury is still working on the booster issue.

“I have to say it’s unclear if everyone needs a booster,” Berkeley said. “We have to obey science.”

Klaus agreed, noting that the lack of clarity is severe for policy makers and the industry.

“From a public health perspective, I’m not sure I don’t need to.” Still, of course, I think this causes planning problems, but it’s not clear that we need to do that either, “Klaus said.

Linley of Airfinity said the company doesn’t know what the future holds in the long run, ten years from now. However, many wealthy countries are purchasing vaccine doses for use as booster immunity over the next few years. “Looking at the next couple of years, I still think it’s a reasonable assumption,” he said. “The influence of Covid because it’s still fresh in people’s minds. It was really devastating.”

The company estimates that 11.3 billion doses were generated and delivered in 2021, but this year’s numbers range from 7 billion to 9.5 billion, and 2.2 billion and 4.4 billion in 2023. May decrease to. Only Pfizer / BioNTech can supply that significant portion.

Manufacturers are aware that this reduction is coming.

Some are trying to hedge their bets by announcing the creation of a vaccine that protects against both the flu and Covid. This is a product that we want to sell every year. However, influenza vaccination is rarely used outside of wealthy countries. Even in those countries, uptake has not approached the replication of the Covid vaccine, which has been a jackpot for sale over the past year.

“If everyone needs the Covid vaccine each year and doesn’t know if autumn will be the best time to administer it, the question is really whether it will be a sustainable strategy.” Klaus said. I was wondering.

Linley pointed out that niche SMEs still developing first-generation Covid vaccines can still be found. Domestic producers in markets without other such options.

“People are very aware of the fact that the major countries that produce vaccines are the first to access those vaccines,” he said, and many countries that are not traditional vaccine production hubs are companies. It is located within their borders as a hedge against the next pandemic, which has suggested that it may find value in purchasing from.

“Sure, countries want to have their own domestic vaccines. It’s possible,” Linley said.