Moderna is asking US regulators to approve what it says could be a remarkably simple proposal to speed up Americans’ immunization against the coronavirus: Fill the empty space in the vials with as much as 50 percent more doses.
The Food and Drug Administration could decide within a few weeks whether Moderna, a Massachusetts-based biotech company that is the developer of one of two federally recognized Covid vaccines, can increase the number of doses in its vials to 15 out of 10. Moderna has the production of his vaccine, but the process of filling, capping and labeling millions of tiny bottles has become a roadblock. The company could produce more if regulators allow it to make fuller bottles, Ray Jordan, a Moderna spokesman, said late Monday.
While it’s not clear how quickly Moderna could adjust its production, any increase could be hugely welcome news in the campaign to curb a pandemic that killed more than 443,000 people in the United States alone.
“This just makes a lot of sense,” said Dr. Nicole Lurie, who served as Assistant Health Secretary for Preparedness and Response under President Barack Obama. If Moderna can use the same size bottle and the same production lines they already use, she said, “it’s a relatively easy and straightforward solution.”
According to data from the Centers for Disease Control and Prevention, Moderna has provided about 46 percent of the vaccine administered in the United States so far. The remainder comes from Pfizer-BioNTech, the only other vaccine developer to receive an emergency permit.
Both vaccines require two doses, and both 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 speed up.
The Biden administration is looking for a way to strengthen production, such as addressing obstacles in the “fill and finish” phase of manufacturing. While that nuts-and-bolts phase gets less attention than the process of making the vaccine itself, it has been identified as a production limitation for years.
Moderna has discussed the possible change with the Food and Drug Administration, but has not yet submitted manufacturing data to support it, people familiar with the discussions said. Federal regulators may be open to the idea of more doses in each vial, but they could refuse to expect a 50 percent increase and approve a more modest number of additional doses instead.
The industry standard has long been 10 doses per vial, and federal regulators may be concerned that too many additional perforations through needles from the rubber vial cover and the time it takes to extract more doses may increase the risk of contamination of the vaccine with bacteria.
At some point, too much liquid can cause a vial to break. Moderna has tested what happens when it adds extra doses and found the limit to be 15, according to people who were familiar with the company’s operations and were not authorized to speak in public.
Moderna’s proposal for the five-dose increase was previously reported by CNBC.
Putting more vaccine in each vial is one of a number of options that the White House and health officials are investigating as they push for production to expand before spring, when officials expect a renewed wave of infections from emerging variants of the coronavirus. Some ideas, such as combining fractions of doses remaining in vials, have been suggested and rejected.
Pfizer is unable to increase the amount of vaccine in the vials because its manufacture is designed for a specific size vial that can only hold about six doses. The Moderna vial 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 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 might be able to make more of its vaccine “relatively quickly” if it were given the green light to add doses to each vial. add.
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Answers to your vaccine questions
Currently, more than 150 million people – nearly half of the population – are eligible for vaccination. But each state makes the final decision on who goes first. The 21 million health workers and three million residents of long-term care facilities were the first to qualify. In mid-January, federal officials urged all states to qualify anyone 65 and older and adults of any age with medical conditions who put them at high risk of becoming seriously ill or dying from Covid-19. Adults in the general population are at the back of the line. If federal and state health officials can resolve bottlenecks in vaccine distribution, anyone 16 and older will be eligible as early as this spring or early summer. The vaccine is not approved in children, although studies are ongoing. It can take months for a vaccine to be available to someone under the age of 16. Visit your state’s health website for current information on vaccination policies in your area
You don’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 for free. Congress passed legislation this spring that prohibits insurers from applying any cost sharing, such as a personal contribution or deductible. It was layered on additional protections that prevented pharmacies, doctors and hospitals from considering patients, including those who are uninsured. Still, health experts worry that patients could get caught in loopholes that leave them vulnerable to surprise bills. This can happen to those who have to pay a doctor visit fee in addition to their vaccine, or Americans who have certain types of health coverage that aren’t covered by the new rules. If you get your vaccine from a doctor’s office or an emergency room, talk to them about possible hidden costs. To make sure you don’t get a surprise bill, it’s best to get your vaccine from a health department vaccination site or local pharmacy once the injections are more widely available.
That has yet to be determined. It’s possible that Covid-19 vaccinations will become an annual event, just like the flu shot. 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 the vaccines is. To determine this, researchers will follow vaccinated people looking for “breakthrough cases” – those people who fall ill with Covid-19 despite vaccination. This is a sign of weakening protection and gives researchers clues about how long the vaccine will last. They will also monitor the levels of antibodies and T cells in the blood of vaccinated people to determine if and when a booster shot may be needed. It is 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 is in surplus,” 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 fill-and-finish problem created a “massive bottleneck” with a limited supply of vaccines.
She said early in the coronavirus pandemic there were discussions at CEPI about what would be the correct vial size for mass vaccinations: five, 10 or 20. Last year, there was a threat of a global shortage of glass vials during negotiations between the federal government and vaccine manufacturers. , putting more stress on pharmaceutical companies developing coronavirus vaccines.
Mr. Yadav said the finish-and-fill process has been automated to prevent contamination and ensure accurate dosing down to the microgram. At top speed, as many as 1,000 vials of vaccine can be filled every minute, he said.
A vial of 15 doses had a tradeoff, he said. It can lead to more wastage if the healthcare provider runs out of people to inoculate and has to discard the remaining doses. But during a raging pandemic, experts said, that 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 is an advisor to the Biden administration until next week, said other major pharmaceutical companies such as Merck or GlaxoSmithKline might be part of the burden of filling and filling. finish podium.
“That’s a more general form of manufacturing activity,” he said.
French drug company 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 package bottles at a Sanofi factory in Frankfurt near BioNTech’s German headquarters. BioNTech, Pfizer’s German partner, designed the vaccine.