Covid-19 variants expose a gap in American drug manufacturing

But Despite early discussions with AstraZeneca and Sanofi by the US government, it is unlikely that any of these companies will start producing shots for variants first if a need arises this year.

AstraZeneca’s original shots are widely used around the world, but not yet available in the United States, but suffer from manufacturing challenges and safety concerns. The company has cut off its relationship with the consignment manufacturer, Emergency Biosolutions, at the request of the government, after an emergency mixture from the AstraZeneca and Johnson & Johnson vaccines. (Contractors focus on Johnson & Johnson shots already in use in the US)

AstraZeneca has not yet sought a permit from the Food and Drug Administration to sell the vaccine in the United States What does the permit look like given the persistent concerns in Europe about rare blood clots associated with vaccines? There are growing questions about. Use of shots for people over 55 years old.

The FDA could follow suit and limit the use of AstraZeneca to the elderly (already the most vaccinated population in the country). This is quoting data from Europe. If a British manufacturer wants to make a revised vaccine, it’s unclear how long it will take and whether Americans want the injection.

“As for boosters, we don’t know if and when booster vaccination is needed at this stage. Clinical trials are underway and more to better understand the persistence of the response. Data will be accumulated, “said an AstraZeneca spokeswoman.

Johnson & Johnson is investigating whether a double dose of the vaccine is better than the current standard single dose, but has not attempted to modify the prescription. Moderna began clinical trials of booster shots and modified vaccines at the National Institutes of Health in late March. Pfizer and its partner BioNTech said they started booster trials with the original vaccine in February and are discussing variant-specific shots with regulators.

These shots are still in laboratory or early human clinical trials, and health officials and pharmaceutical companies say it’s too early to consider producing them on a large scale. However, the potential comes to people’s minds, especially as the B.1.351 and P.1 variants are widespread in the United States and other countries. Both are more contagious than previous versions of the virus, and B.1.351 is deadly.

Several vaccine manufacturers supplying the United States have recently made efforts to expand their production capacity with government support. The Biden administration uses the Defense Production Act to secure Pfizer’s supplies and Engineering Johnson & Johnson Contract with Merck To support vaccine production later this year.This week’s Moderna Long-term contract With a consignment manufacturer.

“The question is how much support the government is doing and how much companies are doing at their own risk.” Preparing for emergencies at the Department of Health and Human Services during President Obama’s time. Nicole Lurie, who led the effort, said. Lurie is currently a Strategic Advisor to the Coalition of Infectious Disease Control Initiatives, one of the leading organizations in the global vaccine equity initiative known as the COVAX Facility.

US officials have already invested billions of dollars to secure hundreds of millions of the first vaccines from Pfizer, Moderna, J & J, AstraZeneca and Novabax. These manufacturers have promised the United States a total of 700 million doses this year. Nonetheless, it’s a huge task that promises to achieve most by this summer.

Since then, the path forward has been vague. Scientists do not yet know how long the vaccine protection will last, and whether a particular strain can overcome the immunoprotection from the first vaccine. Booster shots can occur on a regular basis. And each of these manufacturers needs to continue to produce initial doses in addition to boosters.

“Fortunately, existing vaccines produce neutralizing antibodies that act on mutants,” said a senior government official. “We need more data to determine the persistence of the response. The response can decline over time — expected —”.

Officials added that there are three possible ways: boosting immunity with different doses of existing vaccines, boosting with mutant-targeted vaccines, or combining them known as bivalent vaccines. I will make it what you are doing.

Biden officials are betting that the majority of Americans will be vaccinated before the variant spreads in the United States and requires new shots. However, the ship is sailing in other countries, such as South Africa, competing for shots to protect against variants. B.1.351 and P.1.

“As soon as we have a successful variant vaccine through proper testing, it may be wise to switch to that vaccine in countries where the variant is widespread,” Lurie said.

All of this could be one of the biggest challenges of vaccine diplomacy for US authorities. The Trump administration adopted an “America First” approach to secure vaccines and greatly supported global cooperation on Covid-19, but the Biden team rejoined the international conflict and returned to the World Health Organization. , Has made a quick move to become a COVAX participant. Fair efforts of institutional vaccines.

But, as promised, Biden between the race to protect Americans in the coming weeks and the global effort to defeat the virus before the variants become the world’s biggest problem. There is a careful balance for hitting.

“I’m discussing with you how more vaccines are available to care for all Americans, and we’re in other poor countries: money, time, specialty. We are helping countries around the world who are ignorant, “Biden celebrated in a speech on April 6 with 150 million vaccines in the United States. Vaccines are available all over the world and we are defeating them — viruses from other countries, we are not really completely safe. “

Covid-19 variants expose a gap in American drug manufacturing

Source link Covid-19 variants expose a gap in American drug manufacturing

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