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A new dilemma for Biden virus. How to regulate the vaccine diet?

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WASHINGTON – Officials in the Biden administration predict that coronavirus vaccines will be delivered by mid-May, if not earlier, to exceed US demand, and are struggling to deal with surpluses when vaccine shortages turn into fat.

President Biden has promised enough doses by the end of May to immunize all 260 million adults in the nation. But from then until the end of July, the government blocked manufacturers’ commitments to produce enough vaccines to cover 400 million people, which is 70 million more than the nation’s population as a whole.

Maintaining, modifying, or redirecting those orders is a matter of significant consequences, not only for the nation’s efforts to contain the virus, but also for how quickly the epidemic can end. About three-quarters of vaccine doses worldwide are in just 10 countries. At least 30 countries have not yet injected a single person.

And global scarcity threatens to escalate as nations and regions crack down on vaccine exports. As infections spread, India, a major distributor of vaccines, is now controlling the 2.4 million daily doses produced by a private company there. The move follows a move by the European Union this week to pass emergency legislation suspending vaccine exports for the next six weeks.

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Biden administration officials, who tend to look back on the impending surplus of the United States, point to insufficient need and growing uncertainty. Children and adolescents are not yet vaccinated,: no one is sure if or when immunity can be exhausted, which may require millions of stimulants. shots

“We want to be part of the global solution here,” White said to Psaki, the White House spokesman. But he added: “There are still a number of factors that are unpredictable that we need to plan to the best of our ability, including options, impact, what is most effective, and what works best with children. »

Vaccine Manufacturers որոշ Some high-ranking federal officials say that decisions about additional orders must be made within a few weeks, otherwise uncertainty could slow production lines. The production process can take up to 10 weeks, and changes in the foreign market take time. The rules governing the transportation of vaccines pose “one obstacle, as well as the limited shelf life of the vaccine.”

Bottles from Indiana bottling plants are labeled for home use. If their destination is unclear, either the production line should be discontinued or the bottles for overseas may need to be labeled.

When consignments are shipped to the states, federal regulations prohibit their recall, even if they are not internally required. And the bottles can not stay in storage forever. Although the vaccine itself can be frozen for up to a year, it should be used within four to six months after bottling.

All of these variables threaten to complicate what was a relatively smooth navigation for the Biden administration. In part, thanks to months of determined federal government assistance, vaccine manufacturers are steadily increasing their production, and states are taking new doses as fast as the government can deliver.

Where to go from here is a hotly debated topic.

Clinical trials to determine which vaccines work for adolescents և children ազ of the nation ությամբ are unlikely to die out at the same time. For example, in late spring, Moderna և Pfizer hopes to get intermediate results in how their vaccines work for the nation’s 30 million million teenagers. But Moderna, at least, does not expect results for 12-year-olds until the school year begins next fall.

The administration may have depended on the doses of these two manufacturers while waiting for the results, but then found out that a better option is another vaccine, the testing of which started later, say Johnson & Johnson.

If one or more of the three authorized vaccines are found to provide only short-term protection against COVID-19, amplification shots may require tens of millions more doses. But when that answer will come is also uncertain.

Federal health officials have also been discussing whether to cancel or reduce some of Moderna և Pfizer orders to promise fresh supplies this fall, either baby doses or new vaccine shots that have been modified to work against rapidly spreading versions.

There is a certain incentive for manufacturers to get vaccines that other high-income countries crave. But it will deprive federal officials of deciding which countries receive the overdoses, as well as the humanitarian-diplomatic loan they will receive from sending the vaccine to countries in greater need.

For all these reasons, senior officials say the administration is seeking to maintain its quota, then at some point direct the surplus to other nations in bilateral transactions or give it to COVAX, an international non-profit organization sponsored by the World Trade Organization. to coordinate the fair distribution of vaccines. The Biden administration has already allocated $ 4 billion to these international efforts.

Biden stressed that his main task is to protect Americans, but the pressure is growing on the US stock market. The United States has ordered $ 1 billion in doses from three federally licensed manufacturers, AstraZeneca, whose vaccine has not yet been refined for emergency use in the United States but has been approved by more than 70 countries. It recently announced that it was in talks with Johnson & Johnson for a deal to receive enough shares of 100 100 million.

In total, the supply would be enough to vaccinate 650 million people, which is almost twice the population of the United States. With the highest number of COVID-19 deaths in the world, the United States has fully vaccinated 14% of its population.

The White House announced last week that it would share 4 million doses of the AstraZeneca vaccine with Mexico and Canada, but said no Americans would lose because the vaccine had not yet been delivered here.

That’s a trifle compared to the 300 million doses of AstraZeneca ordered by the federal government, enough to cover the two-dose regimen of 150 million people. Senior administration officials say those tens of millions of doses could be released now or inevitably, tens of millions of unbottled doses could be given.

Brazil especially wants help. With more than 300,000 deaths, the country has the second highest death toll, with less than 2% of its population fully vaccinated.

“Once we take care of the really difficult situation with more than 535,000 deaths in our country, we will obviously have surplus vaccines in the future. Of course, it is being discussed to make this vaccine available to countries that need it.” Dr. Anthony Faus, the government’s chief infectious disease expert, told a White House news conference on Wednesday.

He went to the polls in early May, when the Biden administration called for states to open vaccines for all adults as a turning point. In an interview this week, he said it was likely that anyone who wanted the vaccine would be able to get the vaccine.

Some people do not want to be vaccinated, although their numbers seem to be declining. According to a Pew Research Center poll this month, 69 percent of the population intends to be vaccinated or has already been infected.

The prospects for US production are getting brighter this summer. Pfizer և Moderna together promised enough rations to cover another 100 million people by the end of July.

Pfizer continues to strengthen its product lines. And Moderna hopes to win regulators to increase the dose of each vial by at least 40%, although the lack of special syringes may hinder the program.

According to federal officials, Johnson & Johnson is slowing to increase production in the United States and is now competing to deliver about 24 million doses produced by its Dutch plant by the end of the month. The Food and Drug Administration has just confirmed its new bottling operation in Indiana and is expected to approve vaccine production lines at the Baltimore plant on a daily basis.

But while Johnson & Johnson lags behind other manufacturers, its technology holds great promise for mass production as it can deliver much larger doses for each lot.

Later this year, when Merck & Co. launches the Johnson & Johnson vaccine, it could release 100 million doses a month, or as much as Pfizer and Moderna together give each month. The White House welcomed Johnson & Johnson’s Merck deal, but as production accelerates, those quotas may be required for growing surpluses or exports.

One option is to ship the frozen vaccine overseas, where it can be bottled much cheaper. The federal government says that out of the $ 10 the federal government has agreed to pay for a single dose of Johnson & Johnson vaccine, the drug is only about 30 cents. The rest is the so-called completion costs.

If AstraZeneca gets permission to use US emergency services, it will add even more shots to the mix. Officials expect about 50 million doses to be ready for delivery in May.

But Biden administration officials have been undercover over the AstraZeneca vaccine. It seems to be about as effective as Johnson & Johnson, but requires an extra hit, which means more complex action. Some health officials are concerned that if there are already enough doses in the pipeline to cover every adult who wants a shot, the introduction of a fourth vaccine will simply confuse people.

On the other hand, if the administration decides to donate doses of AstraZeneca without making an offer to its own citizens, other countries may conclude that the United States has no confidence in the safety or efficacy of the vaccine.

“As we gain more confidence in our doses, such as whether or not we have the ability or need to boost, we can make a clearer statement about the role of AZ products in the United States.” In an interview this week, Fauci said it was being cleaned up, “but now I think it ‘s too early to say anything.”

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