US President Joe Biden reiterated in his State of the Union speech on 7 February that the country will end the Covid-19 emergency declaration in May this year. This was previously announced by his administration at the end of January. While the end of the emergency declaration means that Americans may not be able to access free Covid-19 tests, vaccines, and therapeutics, it also poses risks to planned Covid-19 trials.
Currently, 680 industry-sponsored Covid-19 trials are still in the planning stages, according to GlobalData’s Clinical Trials Database. GlobalData is the parent company of Clinical Trials Arena. Most of the planned trials are in early phase.
Sponsors developing injectable Covid-19 vaccines might be compelled to stop their development, says Andrei Floroiu, CEO at Vaxart, which is developing an oral Covid-19 vaccine that completed a Phase II trial last year. Now the company is gearing up for a Phase II human challenge trial in the UK. “We do believe there is still a very strong case to be made to continue developing such vaccines,” he adds.
Rodney Rohde, PhD, chair and professor at the Clinical Laboratory Science Program at Texas State University, agrees that there might be an increase in sponsors abandoning their Covid-19 pipelines. “It will be the big players like [the] Pfizers and Johnson and Johnsons of the world that will hang on because they're in the game and they've got the market share,” he explains.
Funding might dry out
In his speech, Biden also said that while the US has “broken COVID’s grip”, there is still a need to “monitor dozens of variants and support new vaccines and treatments.” However, the end of the emergency status might also mean the end of governmental funding for developers. “I'm concerned that declaring this pandemic over will be more an excuse for the government to stop supporting investments into next-generation vaccines,” says Floroiu.
Floroiu explains that sponsors and the government should continue to invest in new technologies and generation vaccines irrespective of whether the Covid-19 pandemic is over or not. “We should know by now that there is going to be a next pandemic,” he notes.
Developers need to shift their focus to discovering stronger and more stable vaccines or therapeutics that would be able to adapt to the changes of the virus, says Rohde. This will also benefit businesses more effectively in the long term, he adds.
Will EUAs end here?
It is still unclear what the end of the Public Health Emergency (PHE), which was declared under the 319 Public Health Service (PHS) Act, means to Emergency Use Authorisations (EUAs). As previously reported on Clinical Trials Arena, EUAs can be issued beyond the duration of the 319 PHS declaration.
Rohde says this is likely to change in the next few months and the FDA may start reviewing in a more stringent way. “If sponsors will have to go through traditional routes of FDA approval, it will take them way longer to get something approved, especially if they are brand new vaccines and therapeutics,” he explains.
For smaller companies like Vaxart, only time will tell which route they will have to take. Floroiu says the choice of route will depend on the status of the pandemic by the time the companies need to make a decision to either aim for an EUA or go through the traditional process of FDA approval.