Modern is asking U.S. regulators to approve what they say could be a remarkably simple proposal to speed up Americans’ vaccination against the coronavirus: fill the void in its vials with as much as 50 percent more doses.
The Food and Drug Administration may decide within a few weeks whether to allow Moderna, a biotechnology firm in Massachusetts that is the developer of one of the two federally approved Covid vaccines, to increase the number of doses in its vials to 15. 10. Modern has increased the production of its vaccine, but the process of filling, covering and labeling millions of small vials has appeared as a roadblock. The company can produce more if regulators allow it to make fuller bottles, Moderna spokesman Ray Jordan said late Monday.
While it is not clear how quickly Moderna can adjust its production, any increase could be very welcome news in the campaign to quell a pandemic that has killed more than 443,000 people in the United States.
“It makes a lot of sense,” said Dr. Nicole Lurie, who was the assistant health secretary for preparedness and response under President Barack Obama. If Moderna can use the same size bottle and the same production lines he already uses, she said: ‘This is a relatively easy and straightforward solution.’
According to data from the Centers for Disease Control and Prevention, Moderna has delivered about 46 percent of the vaccine administered so far in the United States. The rest comes from Pfizer-BioNTech, the only other vaccine developer to have received emergency approval.
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 faster, the schedule could accelerate.
The Biden administration is looking for any way to boost production, such as addressing barriers in the “filling and finishing” phase of manufacturing. Although the nut-and-bolt stage receives less attention than the process of making the vaccine itself, it has been identified for years as a limitation on production.
According to the people familiar with the discussions, Moderna has discussed the possible change with the Food and Drug Administration, but has not yet submitted manufacturing data to support it. Federal regulators may be receptive to the idea of more doses in each vial, but they may deviate from a 50 percent increase and rather approve a modest number of extra doses.
The industry standard has long been 10 doses per vial, and federal regulators may be concerned that too many additional leaks through the vials of the vial’s rubber coating and the time required to withdraw more doses may increase the risk of vaccinating with to infect bacteria.
At some point, too much liquid can cause a vial to break. Moderna has tested what happens when he adds additional doses and determined that the limit is 15, according to people familiar with the business who are not authorized to speak in public.
Moderna’s proposal for the increase of five doses was reported earlier by CNBC.
Packaging more vaccine in each vial is one of a number of options the White House and health officials are exploring, as they need to expand production before spring, when officials expect a renewed increase in coronavirus variants from emerging variants. Some ideas, such as the combination of fractional doses left in vials, have been proposed and rejected.
Pfizer cannot increase the amount of vaccine in its vials because the manufacture is targeted at a specific size vial that can contain only about six doses. Moderna’s bottle is large enough to hold more than the ten doses currently allowed, so it can add more without creating a new production line.
Asked about Moderna’s proposal, a White House spokesman said Monday that “all options are on the table.”
Prashant Yadav, who studies health care chains at the Center for Global Development in Washington, said Moderna could ‘make’ more of his vaccine ‘relatively quickly’ if he gets the green light to add doses to each vial.
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Answers to your vaccine questions
At present, more than 150 million people can be vaccinated – almost half of the population. But each state makes the final decision about who goes first. The country’s 21 million health workers and three million residents of long-term care facilities were the first to qualify. In mid-January, federal officials called on all states to be eligible for all ages 65 and older and for adults of any age with medical conditions at risk of becoming seriously ill or to Covid-19 to die. Adults in the general population are at the back of the queue. If federal and state health officials can clear up bottlenecks in the distribution of vaccines, everyone 16 years and older will be eligible as early as spring or early summer. The vaccine has not been approved in children, although studies are underway. It can take months for a vaccine to be available to anyone under the age of 16. Visit your health website for recent information on vaccination policies in your area.
You do not have to pay anything out of pocket to get the vaccine, although you will be asked for insurance information. If you do not have insurance, you should still receive the vaccine free of charge. Congress passed this spring legislation that prohibits insurers from applying any cost sharing, such as a co-payment or deductible. It was based on additional protection that pharmacies, doctors and hospitals prevented from patients, including those who were uninsured. Nevertheless, health experts are concerned that patients could end up in loopholes that make them vulnerable to surprising bills. This can happen to those who charge a doctor’s fee along with their vaccine, or Americans who have certain types of health coverage that do not fall under the new rules. If you get your vaccine at a doctor’s office or an urgent clinic, talk to them about possible hidden charges. To make sure you do not get a surprise bill, this is the best way to get your vaccine at a vaccination center or local pharmacy once the shots are more available.
It must be determined. It is 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 longer than a year. We have to wait and see how durable the protection against the vaccines is. To determine this, vaccinated researchers are monitoring people to look for “breakthrough cases” – those who become ill with Covid-19 despite being vaccinated. This is a sign of weakening of protection and will give researchers clues as to how long the vaccine will last. They will also monitor the levels of antibodies and T cells in the blood of vaccines to determine if and when a booster shot is needed. It is possible that people need boosters every few months, once a year or only every few years. It’s just a matter of waiting for the data.
But he said it would not be an immediate change. “I do not think there is a surplus in Moderna,” 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 caused a ‘large bottleneck’ with a limited amount of vaccines.
She said that early in the coronavirus pandemic at CEPI there were discussions about what the appropriate size of the scale for mass vaccinations would be: five, 10 or 20. Last year, the global shortage of glass bottles threatened negotiations between the federal government and vaccine manufacturers, who added more stress to pharmaceutical companies developing coronavirus vaccines.
Mr. Yadav said the finishing-and-fill process is automatic to prevent contamination and to dose the microgram precisely. At its highest speed, as many as 1,000 vials of vaccine can be filled every minute, he said.
A 15-dose vial had a compromise, he said. This can lead to more wastage if the health worker no longer has vaccination and has to discard the remaining doses. But during a raging pandemic, experts said, it could be a risk federal health officials are willing to take.
Dr Moncef Slaoui, who next time will lead the Trump administration’s vaccine development program and is a consultant for the Biden administration until next week, said other major pharmaceutical companies such as Merck or GlaxoSmithKline may be part of the load of the fill and finish stage.
“It’s a more generic kind of manufacturing activity,” he said.
French drugmaker Sanofi announced last week that it would help produce more than 100 million doses of Pfizer-BioNTech vaccine to supply in Europe from this summer. Industry officials said Sanofi would fill and pack bottles in a Sanofi plant in Frankfurt near BioNTech’s German headquarters. BioNTech, the German partner of Pfizer, designed the vaccine.