Vaccination manufacturers and drug regulators outline plans in case the mutating coronavirus alters the development of vaccines in cats and mice.
Only a few weeks after leading manufacturers obtained the first approvals of the regulations, mutations in the virus forced scientists to retest their Covid-19 vaccines and prepare to adjust their formula should the shots be less effective.
At the same time, regulators are considering how they can detect new approvals and whether they can use the seasonal flu stamp as a model to authorize revised versions without the need for lengthy trials.
Scientists are hopeful that the existing crop of vaccines will continue to be effective against the highly transmissible new variants identified in the United Kingdom and South Africa. Initial laboratory tests at the University of Texas found that the BioNTech / Pfizer vaccine still works against one of the major mutations in the United Kingdom and South African variants.
However, the shot has not yet been tested for all mutations in the variant, and Andrew Pollard, director of the Oxford Vaccine Group, has likely warned against dissatisfaction. “We may find ourselves well in a place where they may evade immune responses in the future.”
Andrey Zarur, CEO of Greenlight Biosciences, a biotechnology company that makes an RNA vaccine for messenger, said it makes sense to design new vaccines to “prepare for further power”.
“Then you have a greater chance that your new vaccine will protect against new variants,” said Mr. Zarur said.
BioNTech / Pfizer and Moderna, which were the first manufacturers to launch their experimental Covid vaccines, are well positioned to respond to mutations. The Messenger RNA technology enables the companies to enable custom genetic code in response to any changes in the virus. BioNTech said it could make a new vaccine within six weeks.
Paul Duprex, director of the Center for Vaccine Research at the University of Pittsburgh, said the “beauty” of mRNA is that it uses “humans as factories” to make the protein needed to elicit the immune response.
For other vaccine manufacturers who rely on different technologies, the production process can be more time consuming. Dr Pollard said it may only take a few days to design a new formulation for the adenovirus-based Oxford / AstraZeneca vaccine, but it is much longer to produce.
“The thing that would take time is the production – to take in the new seed, put it in the factory and make millions of new doses,” he said.
Geoffrey Porges, an analyst at healthcare-focused investment bank SVB Leerink, estimated that the entire process, until the new shots were in people’s arms, would take three to six months for the mRNA vaccines. It will take six to eight months for adenovirus vector vaccines such as Oxford / AstraZeneca and Johnson & Johnson, and up to nine months for protein-based vaccines such as those developed by Novavax and Sanofi / GSK, he said.
Healthcare worker Lorraine Parente becomes the first person to receive the Moderna Covid-19 vaccine in Nassau County, New York last week © Kathy Willens / AP
Sanofi, which is already lagging behind after the vaccine did not elicit a strong immune response in older adults, told the Financial Times that it would take longer developmental steps to cover a new virus strain than the mRNA approach, if we new coronavirus should press target “.
The vaccinations that depend on the use of the virus in a dead or attenuated form, such as those of China’s Sinopharm and Sinovac, will also take longer to adapt. Sinopharm and Sinovac did not respond to requests for comment.
Timing will also depend on what the regulators need to approve a vaccinated vaccine. The European Medicines Agency said it was already in talks on what is needed if a change is needed. The U.S. Food and Drug Administration said it was still looking into whether the virus mutated in a way that would make the vaccines less effective.
Both regulators told the Financial Times that the flu vaccine, which is adjusted each year to keep up with the most common strains, could provide a model for a quick approval process.
“We do it every year for flu vaccines,” said Angela Rasmussen, a virologist at Georgetown University. “We do not have to have major clinical trials to make sure it works, but we also had much longer flu vaccines than we had against coronavirus vaccines.”
In normal trials, the effectiveness of a vaccine is assessed by whether vaccine participants are less likely to become infected than those given a placebo. To skip this process, scientists need to have reliable immune system markers that they can use to determine if someone can resist the disease. An example, it me. Rassmussen said, was how many antibodies were needed to neutralize the virus.
Peter Hotez, a vaccination specialist at Baylor College of Medicine, said the FDA should provide more guidance on the studies they need to approve customized vaccines so developers do not have to rediscover the wheel.
In the long run, he said, this problem could be solved by a universal coronavirus vaccine, designed to provide at least partial protection for the whole family of viruses, which also includes Sars and Mers.
The U.S. National Institutes of Health recently invited researchers to apply for funding to create vaccines for coronavirus with pandemic potential. But that would be a big challenge, as many scientists have been trying for decades to create a universal flu vaccine. There have been breakthroughs in the past five years, but two clinical trials failed last year.
Until then, if Covid-19 does change in ways that reduce vaccine efficiency, the companies that work with messenger RNA will have an advantage in an annual vaccination market worth more than $ 10 billion.
“I do not think for a moment that the big companies want a bad virus,” he said. Porges of SVB Leerink said. “But it changes the commercial value of the event substantially.”
Anna Gross in London and Donato Paolo Mancini in Rome