The public health emergency is expiring, so what is the future of COVID-19 vaccines?

This article was first published in MedCity News

The article notes that COVID-19 sent the biotech industry into overdrive to develop vaccines that could tame the novel coronavirus. In relatively short order, and after different kinds of vaccines were researched, we have reached a state where the vast majority of US vaccinations are messenger RNA shots. FDA guidance on booster shots for this fall is still developing, but the picture of what COVID-19 vaccines could look like in the years to come is already taking shape.

If the research pans out, people could get both less and more. The shots will come less frequently, meaning fewer boosters. But a single shot could also offer the potential to protect against more pathogens, such as influenza and respiratory syncytial virus (RSV). These combination shots are still in clinical development, research that is dominated by larger companies. And that’s another consequence of the COVID-19 vaccine race. The chase produced some clear winners – Pfizer/BioNTech and Moderna – and their market dominance, combined with a challenging financing environment, will make it difficult for competitors to catch up.

In the nearer term, companies that have already brought COVID-19 vaccines to the market are focusing on next fall. The FDA last week simplified the COVID-19 vaccination schedule. The original monovalent mRNA shots are no longer authorized. The bivalent vaccines, which protect against the original strain and the prevalent omicron variants, are now authorized for all doses for those age 6 months and older. In another change, the FDA also authorized another booster of the current bivalent shot for the elderly and immunocompromised.

An FDA advisory committee meeting is planned for June to discuss the composition of the vaccines that would be rolled out for the coming fall and winter. The agency said it hoped that making COVID-19 vaccination more closely resemble a seasonal flu shot will prompt more people to take them.

The transitioning vaccine market

Vignesh said that the COVID-19 market is moving from the pandemic state into a “steady state.” The massive government support for developing novel vaccines and accelerating regulatory review is going away. In the steady state, COVID-19 vaccines will more closely resemble seasonal flu vaccines. Flu vaccines are dominated by a handful of big pharma companies: Sanofi, GSK, and Novartis. Just as a large number of new vaccine companies aren’t trying to enter this space each flu season, a large number of COVID-19 vaccine developers won’t be entering the space either, he predicted.

Despite the dominance of mRNA vaccines in the US, Vignesh notes that AstraZeneca’s Vaxzevria, a viral vector vaccine, has more shots in arms globally compared to either the Pfizer or Moderna vaccines. That’s because AstraZeneca struck deals to distribute its shots in places like China, India, and Africa. While AstraZeneca last fall opted not to seek FDA authorization for its shot, saying the US market was already well served, Vignesh said that this vaccine, which is less complex to manufacture and distribute compared to the mRNA shots, can be successful in a steady state environment.

However, Vignesh said there is still room to compete on the mRNA turf of Pfizer and Moderna. The immunity of those shots dissipates after about 90 days. The mRNA vaccine of GSK-partnered CureVac, still in early clinical development, could stand apart if it tops that, he said. The partners are also trying to differentiate by developing shots capable of protecting against multiple coronavirus strain and multiple pathogens, including flu and RSV. Pfizer and Moderna are both also pursuing these such multi-valent vaccines. In the steady state, multivalency will also play a role in reducing the overall number of vaccinations a person would need.

Vignesh adds: “If you can shrink that number of vaccines into combos, or better, more easily available [vaccines], there’s a domino effect on cost and adherence.”

Moderna’s multi-valent vaccine strategy includes a triple vaccine — COVID-19, flu, and RSV in a single shot. That vaccine is in Phase 1 testing. The company is also testing a flu and RSV combination. If these vaccines succeed in clinical trials and receive regulatory approvals, Moderna projects commercial launches starting in 2025, executives said during the company’s annual vaccines day event earlier this month.

Vignesh continued: As long as new vaccine technologies can provide advantages in efficacy and price, they can still provide competition in the US and around the world. The market opportunity in Southeast Asia and Africa is particularly large. As examples of technologies that could offer competition to current vaccines, plant-derived vaccines and oral vaccines. But both types of technologies have encountered setbacks. Medicago’s Covifenz vaccine is made with a virus-like particle that resembles the coronavirus’s spike protein. One advantage of Medicago’s plant-derived vaccines is that they only need standard refrigerator temperatures. Last year, Canada approved the Quebec-based company’s vaccine.

Vignesh expects that in the steady state world, COVID-19 vaccine developers will find recruiting patients and running clinical trials will be similar to conducting studies for other infectious diseases, such as flu or pneumococcal disease. In other words, it won’t be anything like it was at the height of the pandemic when COVID-19 studies were able to recruit large numbers of patients very quickly. Vaccine companies will need to plan for their trials to take much longer. He does not see a significant amount of investment going toward vaccine research beyond what’s being done by the market leaders. But looking at the COVID-19 market broadly, he sees more opportunity in research of new therapeutic options, particularly for treating moderate-to-severe disease.

Vignesh concludes: “I don’t believe that space has been adequately served during the pandemic, and in the steady state environment, I see more opportunity in the treatment side.”