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Moderna is calling on US regulators to approve what he says could be a remarkably simple proposal to speed up the vaccination of Americans against the coronavirus: fill the empty space in its vials with up to 50% more doses.
The Food and Drug Administration could decide in a few weeks to allow Moderna, a Massachusetts-based biotech company that is the developer of one of two federally licensed Covid vaccines, to increase the number of doses in its vials. up to 15 of 10. Moderna has ramped up production of its vaccine, but the process of filling, capping and labeling millions of tiny vials has become an obstacle. The company could produce more if regulators allowed it to make fuller bottles, a Moderna spokesperson Ray Jordan said on Monday.
While it’s not clear how quickly Moderna could adjust production, any increase could be much welcome news in the campaign to stem a pandemic that has killed more than 443,000 people in the United States alone.
“It just makes a lot of sense,” said Dr Nicole Lurie, who was assistant secretary of health for preparedness and response under President Barack Obama. While Moderna can use the same bottle size and the same production lines that it already uses, she says, “it’s a relatively simple and straightforward solution.”
Moderna has delivered about 46% of the vaccine that has been given so far in the United States, according to data from the Centers for Disease Control and Prevention. The rest comes from Pfizer-BioNTech, the only other vaccine developer to have received emergency clearance.
Both vaccines require two doses, and the two companies have pledged to deliver 200 million doses by July. That would be enough to cover about three quarters of the country’s adults. If Moderna can deliver doses faster, that schedule could accelerate.
The Biden administration is looking for any way to increase production, such as resolving obstacles in the “fill and finish” phase of manufacturing. Although this “nut-and-bolt” step receives less attention than the vaccine manufacturing process itself, it has been identified for years as a production constraint.
Moderna has discussed the possible change with the Food and Drug Administration but has yet to submit manufacturing data to support it, people familiar with the discussions said. Federal regulators might be receptive to the idea of more doses in each vial, but they might balk at a 50% increase and instead approve a more modest number of additional doses.
The industry standard has long been 10 doses per vial, and federal regulators may be concerned that too many additional punctures by needles from the rubber coating of the vial and the time required to extract more doses may increase the risk of contamination. of the vaccine by bacteria.
At one point, too much liquid can cause a vial to rupture. Moderna has tested what happens when he adds extra doses and determined that the limit is 15, according to people familiar with the company’s operations who were not authorized to speak publicly.
Moderna’s proposal for the five-dose increase was reported earlier by CNBC.
Packing more vaccine in each vial is one of the many options the White House and health officials are exploring as they attempt to ramp up production before spring, when officials expect another surge in infections due to emerging variants of the coronavirus. Some ideas, such as combining fractions of doses remaining in vials, were proposed and rejected.
Pfizer is unable to increase the amount of vaccine in its vials as its manufacture is geared towards a particular vial size which can only hold approximately six doses. Moderna’s vial is large enough to hold more than the 10 doses currently allowed, so it could add more without creating a new production line.
When asked about Moderna’s proposal, a White House spokesman said Monday that “all options are on the table.”
Prashant Yadav, who studies health care supply chains at the Center for Global Development in Washington, said Moderna may be able to produce more of its vaccine “relatively quickly” if it is given the green light to add doses in each vial.
Vaccines against covid19>
Answers to your questions about vaccines
Currently, more than 150 million people – almost half of the population – are eligible for vaccination. But each state makes the final decision as to who starts. The country’s 21 million healthcare workers and three million residents of long-term care facilities were the first to qualify. In mid-January, federal officials urged all states to open eligibility to all people 65 and older and adults of all ages with health conditions that put them at high risk of becoming seriously ill. or die from Covid-19. The adults of the general population are at the back of the pack. If federal and state health authorities can remove the bottlenecks in vaccine distribution, everyone 16 and older will become eligible as early as this spring or early summer. The vaccine has not been approved in children, although studies are ongoing. It can take months for a vaccine to be available to anyone under the age of 16. Visit your state’s website for up-to-date information on immunization policies in your area.
You shouldn’t have to pay anything out of pocket to get the vaccine, although you will be asked for insurance information. If you don’t have insurance, you should still get the vaccine at no cost. Congress passed a law this spring that prohibits insurers from enforcing any cost sharing, such as a copayment or deductible. It was based on additional protections prohibiting pharmacies, doctors and hospitals from billing patients, including those who are uninsured. Even so, health experts fear that patients will stumble upon loopholes that expose them to surprise bills. This could happen to those who are charged a doctor’s visit fee with their vaccine, or to Americans who have certain types of health coverage that do not fall under the new rules. If you get your vaccine from a doctor or emergency care clinic, tell them about any hidden costs. To make sure you don’t get a surprise bill, your best bet is to get vaccinated at a health service vaccination site or local pharmacy once vaccines become more widely available.
This remains to be determined. It is possible that the Covid-19 vaccination will become an annual event, just like the flu vaccine. Or it could be that the benefits of the vaccine last for more than a year. We have to wait and see how durable the protection against vaccines is. To determine this, researchers will follow vaccinated people looking for “revolutionary cases” – those people who contract Covid-19 despite being vaccinated. This is a sign of weakening protection and will give researchers clues about how long the vaccine will last. They will also monitor the levels of antibodies and T cells in the blood of people who have been vaccinated to determine if and when a booster injection might be needed. It’s conceivable that people will need boosters every few months, once a year, or just every few years. It’s just a matter of waiting for the data.
But he said it wouldn’t be an instant change. “I don’t think Moderna has a surplus,” he says.
Dr Lurie, adviser to the Coalition for Epidemic Preparedness Innovations, known as CEPI, said that during the federal government’s response to the H1N1 swine flu, the problem of filling and finishing caused a “huge bottleneck ”with a limited supply of vaccines.
She said there were discussions at CEPI early in the coronavirus pandemic over the appropriate vial size for mass vaccinations: five, 10 or 20. Last year, global shortages of glass vials loomed during negotiations between the federal government and vaccine makers, adding more stress on pharmaceutical companies developing coronavirus vaccines.
Mr Yadav said the finishing and filling process was automated to avoid contamination and ensure accurate dosing to the microgram. At maximum speed, up to 1,000 vaccine vials can be filled every minute, he said.
A 15-dose vial involved a trade-off, he said. This could lead to more waste if the healthcare professional runs out of people to immunize and has to throw away the remaining doses. But during a raging pandemic, experts said, it could be a risk federal health officials would be willing to take.
Dr Moncef Slaoui, who helped lead the Trump administration’s vaccine development program and who is a consultant to the Biden administration until next week, said other big pharmaceutical companies like Merck or GlaxoSmithKline may be able to shoulder some of the burden of filling and filling. arrival stage.
“It’s a more generic type of manufacturing activity,” he said.
French drug maker Sanofi announced last week that starting this summer, it will help produce more than 100 million doses of the Pfizer-BioNTech vaccine to meet demand in Europe. Company officials said Sanofi will fill and pack vials at a Sanofi factory in Frankfurt, near the German headquarters of BioNTech. BioNTech, Pfizer’s German partner, designed the vaccine.
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