Biden and Drug Makers Look to Speed Coronavirus Vaccine Deliveries – The New York Times

WASHINGTON — As President Biden winds up his second week in office, a flurry of developments in vaccine production and distribution could mean a bigger boost to coronavirus vaccine supplies than was expected even just days ago.

Moderna, one of two developers of federally authorized coronavirus vaccines, is asking U.S. regulators to approve what it says could be a remarkably simple proposal to speed up the immunization of Americans against the coronavirus: Fill empty space in its vials with as many as 50 percent more doses.

Moderna currently produces about half of the nation’s vaccine stock. If the change is approved — which could happen in weeks — it could ultimately add tens of millions of more doses to vaccine supplies.

At the same time, the White House announced on Tuesday that it was enlisting more retail pharmacies as a channel to distribute vaccines. Jeffrey D. Zients, the White House’s coronavirus response coordinator, said the federal government would send a million doses to around 6,500 retail pharmacies on Feb. 11, the beginning of a federal program that eventually is expected to deliver vaccines directly to 40,000 pharmacies.

The White House announcements were clearly intended to show that Mr. Biden was making rapid strides on the vaccine front amid huge frustration in the country over tight supplies and a chaotic, cobbled-together system for administrating the available shots. But the developments also indicated that the government was gradually expanding the way people can get their immunizations and the number of shots available.

The prospect of greater supplies offered at least a glimmer of hope that many Americans might not have to wait until midsummer or later to be vaccinated while new variants spread the virus more rapidly and the nation’s death toll, now nearing 445,000 people, grows.

For weeks, many health experts inside and outside the federal government have despaired over the United States’ ability to produce more than about 220 million doses that Pfizer and Moderna say they are on track to deliver by the end of next month. The spring is critical because health experts have warned that the nation could be in the grip of even more contagious variants of the virus by then.

Because both Pfizer’s and Moderna’s vaccines require two doses, the supply the companies have promised would cover only 110 million of the nation’s 260 million adults eligible to be inoculated. A third vaccine developer, Johnson & Johnson, is expected to seek approval for its vaccine for emergency use soon, but might be able to deliver only as few as seven million doses before April.

Fuller vials from Moderna could brighten the outlook. As the company ramped up its manufacturing of its drug over recent weeks, officials said, it realized that the process of filling, capping and labeling millions of tiny vials was a roadblock to increasing output. Were regulators to raise the number of doses that could be put in one vial, Moderna could deliver more vaccine faster, Ray Jordan, a company spokesman, said late Monday.

“This just 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 of vial and the same production lines it is already running, she said, “it’s a relatively easy and straightforward fix.”

Prashant Yadav, who studies health care supply chains at the Center for Global Development in Washington, said Moderna should be able to make factory adjustments to produce fuller vials fairly quickly.

If too many doses are added to a vial, it can break. Moderna officials ran a series of tests and determined the upper limit was 15. Unlike Pfizer, whose manufacturing is geared to a vial limited to about six doses, Moderna’s was big enough to hold the industry standard of 10 doses, in addition to some more, according to people familiar with the companies’ operations.

As the Biden administration has searched for any way to bolster production, addressing obstacles in the “fill and finish” phase of manufacturing has increasingly become a focal point. That nuts-and-bolts stage receives less attention than the process of making the vaccine itself, but it has been identified for years as a constraint on production.

Company officials have discussed the option of added doses with the Food and Drug Administration, but have not yet submitted data to justify it, they said. Federal regulators might be receptive to the idea but could approve a more modest increase than Moderna is seeking, partly out of concern that too many additional punctures by needles of the rubber covering of the vial could increase the risk of contaminating the vaccine.

Asked about Moderna’s proposal, a White House spokesman said only that “all options are on the table.”

Covid-19 Vaccines ›

Answers to Your Vaccine Questions

Currently more than 150 million people — almost half the population — are eligible to be vaccinated. But each state makes the final decision about who goes first. The nation’s 21 million health care 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 up eligibility to everyone 65 and older and to 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 back of the line. If federal and state health officials can clear up bottlenecks in vaccine distribution, everyone 16 and older will become eligible as early as this spring or early summer. The vaccine hasn’t been approved in children, although studies are underway. It may be months before a vaccine is available for anyone under the age of 16. Go to your state health website for up-to-date information on vaccination policies in your area

You should not 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 be given the vaccine at no charge. Congress passed legislation this spring that bars insurers from applying any cost sharing, such as a co-payment or deductible. It layered on additional protections barring pharmacies, doctors and hospitals from billing patients, including those who are uninsured. Even so, health experts do worry that patients might stumble into loopholes that leave them vulnerable to surprise bills. This could happen to those who are charged a doctor visit 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 from a doctor’s office or urgent care clinic, talk to them about potential hidden charges. To be sure you won’t get a surprise bill, the best bet is to get your vaccine at a health department vaccination site or a local pharmacy once the shots become more widely available.

That is to be determined. It’s possible that Covid-19 vaccinations will become an annual event, just like the flu shot. Or it may be that the benefits of the vaccine last longer than a year. We have to wait to see how durable the protection from the vaccines is. To determine this, researchers are going to be tracking vaccinated people to look for “breakthrough cases” — those people who get sick with Covid-19 despite vaccination. That is a sign of weakening protection and will give researchers clues about how long the vaccine lasts. They will also be monitoring levels of antibodies and T cells in the blood of vaccinated people to determine whether and when a booster shot might be needed. It’s conceivable that people may need boosters every few months, once a year or only every few years. It’s just a matter of waiting for the data.

Among other efforts, Mr. Zients said that the government had now ensured that specialized syringes were shipped out with Pfizer’s vials so practitioners could extract a sixth dose from them. Albert Bourla, Pfizer’s chief executive, told investors Tuesday that the company was now two months ahead of schedule and expected to deliver a total of 200 million doses for Americans by the end of May instead of the end of July. The acceleration is at least partly because the government has decided to count Pfizer vial as six doses instead of five.

The introduction of pharmacies will be the start of a new stage in the nation’s vaccination campaign. So far the drive has been centered in hospitals, other health care facilities and big sites like stadiums. Officials hope smaller settings like pharmacies will increasingly play a role.

Some states are already delivering doses to a limited number of pharmacies; the federal program will not cut into that supply of doses, officials said.

The debut of the program will be slow at first — many pharmacies will not have vaccines at all or will have very limited supply, Mr. Zients said — and it will not expand the still-limited number of high-risk groups that states have deemed to be eligible to receive vaccines. Eligible patients should check pharmacy websites for availability, Mr. Zients said.

Mr. Zients said that the federal government would allocate vaccines under the pharmacy program based on the population of each state and jurisdiction, as it has been doing for vaccines distributed through other channels.

The Centers for Disease Control and Prevention is also working with states to choose pharmacies in areas that are “harder to reach” and close to people at higher risk of severe cases of Covid-19, Mr. Zients said. He added that the agency would monitor the program to make sure pharmacies were distributing doses efficiently and fairly.

Dozens of pharmacies and grocery stores, including both national and regional chains, are participating in the program, but not all will be involved in its initial phase. Among them are CVS, Walgreens, Walmart, Rite Aid, Kroger, Publix, Meijer, Costco, Jewel-Osco and Safeway.

The expansion of the vaccine rollout to more retail pharmacies will come with new logistical challenges, as well as many of the same ones that have bedeviled the rollout so far. Pharmacies will have to find space in their stores or other locations to give out vaccines. They will need to carefully document the shots, as well as to remind people to come back for their second doses. Pharmacists and support staff will also need to keep people socially distanced and watch them afterward for side effects — while also handling all the usual demands of a busy drugstore.

“It’s not just a matter of drawing up a syringe, you run out, you jab them in the arm, and you come right back,” said Adam Nachand, a Minnesota pharmacist who has spent most of his 20-year career working in retail pharmacies and is currently working for Walgreens giving out vaccines in long-term care facilities. “You have to still be able to manage that with enough time to deliver the care, do the screening, answer their questions, monitor them, etc. — and you still have a pharmacy to run.”

Sharon LaFraniere and Noah Weiland reported from Washington, and Rebecca Robbins from Bellingham, Wash. Katie Thomas contributed reporting from Chicago.