Moderna is asking US regulators to approve what it says is an extremely simple proposal to speed up Americans’ immunization against the coronavirus: fill the empty space in their bottles with up to 50% more doses.
The Food and Drug Administration may decide in a few weeks whether to allow Moderna, a Massachusetts-based biotechnology company that is the developer of one of two federally authorized Covid vaccines, to increase the number of doses in its bottles by up to 15 de 10. Moderna has increased the production of its vaccine, but the process of filling, capping and labeling millions of tiny vials has come up as an obstacle. The company could produce more if regulators allow the manufacture of fuller bottles, said Ray Jordan, spokeswoman for Moderna, on Monday night.
While it is unclear how quickly Moderna could adjust its production, any increase could be very welcome news in the campaign to contain a pandemic that killed more than 443,000 people in the United States alone.
“It makes a lot of sense,” said Dr. Nicole Lurie, who was assistant secretary of health for preparedness and response under President Barack Obama. If Moderna can use the same bottle size and the same production lines in which it is already operating, she said, “it is a relatively easy and straightforward solution”.
Moderna distributed about 46 percent of the vaccine that has been administered so far in the United States, according to data from the Centers for Disease Control and Prevention. The rest came from Pfizer-BioNTech, the only other vaccine developer that received emergency clearance.
Both vaccines require two doses, and both companies have promised 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 more quickly, that schedule may accelerate.
The Biden government is looking for some way to boost production, such as addressing obstacles in the “filling and finishing” phase of manufacturing. Although this stage of nuts and bolts receives less attention than the vaccine manufacturing process itself, it has been identified for years as a production restriction.
Moderna discussed the possible change with the Food and Drug Administration, but has yet to provide manufacturing data to support it, people familiar with the discussions said. Federal regulators may be receptive to the idea of more doses in each bottle, but they may hesitate to increase it by 50 percent and instead approve a more modest number of extra doses.
The industry standard has been 10 doses per bottle, and federal regulators may be concerned that too many additional needle punctures in the bottle’s rubber cover and the time required to extract more doses may increase the risk of contamination of the bottle. vaccine with bacteria.
At some point, too much liquid can cause the bottle to break. Moderna tested what happens when adding additional doses and determined that the limit is 15, according to people familiar with the company’s operation who were not allowed to speak publicly.
Moderna’s proposal to increase five doses was previously reported by CNBC.
Putting more vaccine in each vial is one of several options that the White House and health officials are exploring as they push to expand production before spring, when authorities expect a new outbreak of infections from emerging variants of the coronavirus. Some ideas, such as combining fractions of doses left over in bottles, were proposed and rejected.
Pfizer is unable to increase the amount of vaccine in its vials because its manufacture is aimed at a specific vial size that can contain only about six doses. The Moderna bottle is large enough to hold more than the 10 doses currently allowed, so it can add more without creating a new production line.
When asked about Moderna’s proposal, a White House spokesman said on Monday that “all options are on the table”.
Prashant Yadav, who studies health supply chains at the Center for Global Development in Washington, said Moderna may be able to “relatively quickly” produce more of its vaccine if it receives the green light to add doses to each vial.
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Answers to your vaccine questions
Currently, more than 150 million people – almost half the population – can be vaccinated. But each state makes the final decision about who goes first. The country’s 21 million health workers and three million residents in long-term care facilities were the first to qualify. In mid-January, federal authorities urged all states to open eligibility for all people aged 65 and over and adults of any age with medical conditions that put them at high risk of becoming seriously ill or dying from Covid-19. . Adults in the general population are at the rear of the line. If federal and state health officials can resolve bottlenecks in vaccine delivery, all 16 years and older will be eligible as early as this spring or early summer. The vaccine has not been approved in children, although studies are ongoing. It may take months before a vaccine is available to anyone under the age of 16. Go to your state’s health website for up-to-date information on vaccination policies in your area
You should not have to pay anything out of your pocket to get the vaccine, although insurance information is requested. Even if you are not insured, you should receive the vaccine free of charge. Congress passed legislation this spring that prohibits insurers from applying any cost sharing, such as copayment or deductibles. He imposed additional protections, preventing pharmacies, doctors and hospitals from charging patients, including those without insurance. Even so, health experts fear that patients may run into gaps that leave them vulnerable to unexpected bills. This can happen for those who pay a medical consultation fee with their vaccine, or Americans who have certain types of health coverage that do not fall under the new rules. If you get the vaccine at a doctor’s office or urgent care clinic, talk to them about possible hidden costs. To make sure you don’t get a surprise bill, the best bet is to get your vaccine at a vaccination post in the health department or at a local pharmacy as soon as the vaccines are more widely available.
This must be determined. It is possible that Covid-19 vaccines will become an annual event, as well as the flu vaccine. Or it may be that the benefits of the vaccine last for more than a year. We have to wait to see how durable vaccine protection is. To determine this, the researchers will screen vaccinated people for “innovative cases” – those who fall ill with Covid-19 despite the vaccination. This is a sign of weakened protection and will give researchers clues as to how long the vaccine lasts. They will also monitor the levels of antibodies and T cells in the blood of vaccinated people to determine if and when a booster injection may be needed. It is conceivable that people need reinforcements every few months, once a year or just every few years. It is just a matter of waiting for the data.
But he said it would not be an instant change. “I don’t think Moderna has a surplus out there,” he said.
Dr. Lurie, an adviser to the Coalition for Epidemic Preparedness Innovations, known as CEPI, said that during the federal government’s H1N1 swine flu response, the problem of filling and finishing caused a “huge bottleneck” with a limited supply of vaccines.
She said there were discussions at CEPI at the start of the coronavirus pandemic about what the appropriate bottle size would be for mass vaccinations: five, 10 or 20. Last year, the global shortage of glass bottles hovered over government negotiations federal government and vaccine manufacturers, adding more stress to pharmaceutical companies that develop coronavirus vaccines.
Mr. Yadav said that the finishing and filling process was automated to avoid contamination and to ensure the precise dosage for the microgram. At full speed, up to 1,000 vials of vaccine can be filled each minute, he said.
A 15-dose bottle had an offset, he said. It can result in more waste if the healthcare professional runs out of people to inoculate and has to discard the remaining doses. But during a violent pandemic, experts said, this could be a risk that federal health officials would be willing to take.
Dr. Moncef Slaoui, who helped lead the Trump administration’s vaccine development program and is a consultant to the Biden administration next week, said that other large pharmaceutical companies like Merck or GlaxoSmithKline may be able to take part of the burden of filling and final phase.
“This is a more generic type of manufacturing activity,” he said.
French pharmaceutical Sanofi announced last week that, starting this summer, it would help produce more than 100 million doses of the Pfizer-BioNTech vaccine to meet demand in Europe. Company officials said Sanofi would fill and pack bottles at a Sanofi factory in Frankfurt near BioNTech’s German headquarters. BioNTech, German partner of Pfizer, developed the vaccine.