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Covid-19 variants expose drug manufacturing deficit in the United States

But Despite the US government’s initial conversations with AstraZeneca and Sanofi, either of these companies is unlikely to be among the first to begin manufacturing plans for variants if the need arises this year .

AstraZeneca’s original shot, widely used around the world but not yet available in the United States, is bogged down by manufacturing challenges and safety concerns. The company is severing ties with a contract manufacturer, Emergent BioSolutions, at the request of the government after the Emergent mixed ingredients of the AstraZeneca and Johnson & Johnson vaccines. (The entrepreneur will now focus on the Johnson & Johnson snapshot, already in use in the United States)

AstraZeneca has yet to seek approval from the Food and Drug Administration to market its vaccine in the U.S. There are growing questions about what the approval might look like given lingering concerns in Europe about rare vaccine-related blood clots, which have prompted several countries to restrict the use of shooting to people 55 years of age and older.

The FDA may do the same and limit the use of AstraZeneca to the elderly – already the most vaccinated population in the country – citing data outside of Europe. If the British manufacturer wanted to produce a revised vaccine, it’s unclear how long it could take and whether Americans will want the vaccine.

“Regarding the booster shots, at this point we are unable to say if or when booster vaccinations will be needed. Clinical trials are underway and more data will be collected to better understand the sustainability of the response, ”said a spokesperson for AstraZeneca.

Johnson & Johnson is investigating whether two doses of its vaccine surpass the single dose that is now standard, but it has not tried to revise its formula. Moderna began a clinical trial of a booster and a modified vaccine with the National Institutes of Health at the end of March. Pfizer and its partner BioNTech began a booster trial with their original vaccine in February and said they were in talks with regulators about a variant-specific vaccine.

With these pictures still in the lab or the first human trials, health officials and pharmaceutical companies say it’s too early to consider producing them on a large scale. But the possibility is on people’s minds, especially as the B.1.351 and P.1 variants have spread to the United States and other countries. Both are more contagious than earlier versions of the virus and B.1.351 is more deadly.

Several vaccine manufacturers supplying the United States have recently made efforts to increase their manufacturing capacity, some with government assistance. The Biden administration used the Defense Production Act to secure some supplies from Pfizer and claimed engineering credit for Johnson & Johnson’s deal with Merck for vaccine production aid later this year. Moderna this week announced a long-term deal with a contract manufacturer.

“The question is, to what extent are companies doing at their own risk compared to what the government is supporting?” said Nicole Lurie, who led the Department of Health and Human Services’ emergency preparedness efforts during Obama’s presidency. Lurie is now a strategic advisor to the Coalition for Epidemic Preparedness Initiatives, one of the organizations leading the global vaccine equity effort known as the COVAX Facility.

US authorities have already distributed billions of dollars to obtain hundreds of millions of doses of the first vaccines from Pfizer, Moderna, J&J, AstraZeneca and Novavax. These manufacturers have pledged 700 million combined doses to the United States this year – a gargantuan task that they nevertheless promise to be able to accomplish in large part by this summer.

From there, the road becomes foggy. Scientists still do not know how long the protection against vaccines lasts and whether certain strains can overcome the immune protection of the initial vaccines. Booster shots may become a regular occurrence. And each of these manufacturers will have to continue to produce initial doses in addition to any recalls.

“The good news is that existing vaccines generate neutralizing antibodies that work against the variants,” a senior administration official said. “We need more data to determine the sustainability of this response. It is likely – it is expected – that this response will diminish over time. “

The official added that there were three ways forward: boosting immunity with another dose of existing vaccines, increasing with a vaccine targeting variants, or combining these into what’s called a bivalent vaccine.

Biden officials are betting the vast majority of Americans will be vaccinated before the variants spread so widely in the United States that more shots are needed – but this ship has sailed to other countries, such as South Africa. South, who jostle for shots that protect against variants like B.1.351 and P.1.

“I think as soon as there is a variant vaccine that has passed the appropriate trials, it may be prudent to just switch to that vaccine, certainly in countries where the variant is prevalent,” Lurie said.

All of this could constitute one of the biggest tests of vaccine diplomacy for US officials. While the Trump administration has largely resisted global cooperation on Covid-19, taking an “ America First ” approach to securing vaccines, the Biden team has taken early steps to join the international fray, returning at the World Health Organization and becoming a participant in COVAX. Equity effort in vaccines in facilities.

But there is a careful balance for Biden to strike a balance between racing to protect Americans in a matter of weeks, as promised, and launching the global effort to defeat the virus before the variants become the biggest problem in the world. world.

“I’m talking to all of you about how we even have access to more vaccines than we need to care for all Americans. And we are helping other poor countries – countries around the world that don’t have the money, the time, the expertise, ”Biden said in an April 6 speech celebrating 150 million strokes administered to people. United States. the vaccine is available around the world and we are counterattacking the vaccine – the virus in other countries, we are not really completely sure. “

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