But Despite the U.S. government’s early talks with AstraZeneca and Sanofi, either of those companies is unlikely to be among the first to produce recordings for variants if needed this year.
AstraZeneca’s original shot, which is widely used around the world but not yet available in the US, is fraught with manufacturing challenges and safety concerns. The company is severing its relationship with a contract manufacturer, Emergent BioSolutions, at the request of the government after Emergent blended ingredients were created from AstraZeneca and Johnson & Johnson vaccines. (The contractor will now focus on the Johnson & Johnson shot, which is already in use in the U.S.)
AstraZeneca has not yet asked the Food and Drug Administration for permission to commercialize its vaccine in the United States. There are growing questions about what approval might look like if there are persistent concerns in Europe about rare blood clots related to the vaccine, which has led several countries to restrict use of the shot for people aged 55 and over.
It’s possible the FDA could follow suit and restrict AstraZeneca use to the elderly – already the most heavily vaccinated population in the country – citing data from Europe. If the British manufacturer wanted to make a revised vaccine, it’s unclear how long it could take and whether the Americans want the shot.
“With regard to boosters, we cannot currently say whether or when booster vaccinations will be required. Clinical trials are ongoing and more data is being collected to better understand the durability of the response, ”said an AstraZeneca spokesman.
Johnson & Johnson is investigating whether two doses of its vaccine will exceed the current single dose, but has not tried to revise its formula. Moderna began a clinical trial with a booster shot and a modified vaccine at the National Institutes of Health in late March. Pfizer and its partner BioNTech started a booster study with their original vaccine in February and said they were in talks with regulators about a variant-specific shot.
With these recordings still in the laboratory or in early human studies, health officials and drug companies say it is too early to think about making them on a large scale. However, the possibility lies in people’s minds, especially since variants B.1.351 and P.1 are spreading in the US and other countries. Both are more contagious than previous versions of the virus, and B.1.351 is more deadly.
Several US vaccine manufacturers have recently made efforts to expand their manufacturing capabilities, some with government support. The Biden government used the Defense Manufacturing Act to secure some Pfizer shipments and sought recognition of Johnson & Johnson’s contract with Merck to assist in vaccine manufacturing later that year. Moderna announced one this week long term deal with a contract manufacturer.
“The question is how much of it the companies do at their own risk and how much the government supports.” said Nicole Lurie, who led emergency preparedness for the Department of Health and Human Services during the Obama presidency. Lurie is now a strategic advisor to the Coalition for Epidemic Preparedness Initiatives, one of the organizations leading the global effort for vaccine justice known as the COVAX Facility.
US authorities have already spent billions of dollars getting hundreds of millions of doses of the first vaccines from Pfizer, Moderna, J&J, AstraZeneca and Novavax. These manufacturers have promised the US a total of 700 million cans this year – a gigantic task that they nevertheless promise to largely accomplish by the summer.
From then on, the road ahead becomes cloudy. Scientists still don’t know how long protection from vaccines will last and whether certain strains can overcome immune protection from the first vaccines. Booster shots can occur regularly. And each of these manufacturers must continue to produce starting doses in addition to the boosters.
“The good news is that the vaccines that are in place produce neutralizing antibodies that work against the variants,” said a senior administration official. “We need more data to determine the durability of this reaction. It is likely – it is expected – that this reaction will wear off over time. “
The official added that there are three options: boosting immunity with a different dose of existing vaccines, boosting with a vaccine that targets variants, or combining those vaccines into what is known as a bivalent vaccine.
Biden officials are betting on vaccinating the vast majority of Americans before variants spread enough in the US that new shots are needed – but this ship has sailed other countries like South Africa looking for shots that preceded variants like protect B.1.351 and P.1.
“I think once there is a vaccine variant that has gone through the appropriate studies, it may be advisable to switch to just that vaccine, certainly in countries where the variant is prevalent,” said Lurie.
All of this could represent one of the greatest tests of vaccine diplomacy for US officials. While the Trump administration largely opposed global collaboration on Covid-19 and took an “America First” approach to vaccine security, the Biden team took early steps to rejoin the international fight, return to the World Health Organization, and Participate in the COVAX equity effort for vaccines.
But there’s a careful balance for Biden to strike between the race to protect Americans in a few weeks as promised and global efforts to fight the virus before variants become the world’s biggest problem.
“I’m talking to you about how we can even have access to more vaccines than we need to care for any American. And we’re helping other poor countries – countries around the world that don’t have the money, time, and money have the expertise, ”Biden said in an April 6 speech celebrating 150 million shots given in the US The vaccine is available to the world and we are repelling the vaccine – the virus in other countries is not really sure. “