U.S. poised to have 3M vaccine doses available per day by April

The United States is on track to have three million coronavirus vaccine doses per day available by April, according to numbers shared by major manufacturers in a congressional hearing Tuesday.

Vaccine providers including Pfizer and Moderna, makers of already authorized shots, appeared before a House panel just before an influx of shots could arrive in federal coffers. Pfizer said Tuesday that it can bump supplies from four to five million shots a week currently to 13 million doses per week by mid-March, while Moderna said it can double its supplies to provide more than 40 million doses per month by April.

That could roughly double the pace of vaccination from roughly 1.5 million shots per day now.

Those figures do not factor in potential doses of Johnson & Johnson's vaccine, which FDA is expected to authorize as early as this weekend. The company said it can deliver 20 million doses of its vaccine — which is given as a single shot, unlike Moderna and Pfizer's two-dose regimens — by the end of March.

While there were reports last month that manufacturing snags could delay J&J's early shipments, Richard Nettles, vice president of medical affairs for the company's Janssen pharmaceutical unit, told the House panel that nearly four million doses will be ready to ship when the vaccine is authorized for use.

White House officials told governors on Tuesday that about 2 million doses of J&J's vaccine should be available next week, with smaller amounts shipping to states in the following two weeks, three sources said. An administration official confirmed the 2 million figure, contingent on an emergency use authorization.

J&J declined to comment on how much vaccine would be available at first, instead reiterating its target of 20 million doses by late March.

AstraZeneca and Novavax, the other vaccine makers whose executives appeared before the House Energy and Commerce Subcommittee on Oversight and Investigations, have not filed for FDA review yet — but they are also stockpiling shots in preparation for rollout.

All of the executives stressed that they are looking for ways to increase production to meet the overwhelming demand from the largest global vaccination campaign in history. And all said they do not anticipate essential material shortages — supplies spanning from vaccine ingredients to syringes, stoppers and others — in meeting their current production goals.

“We understand the significant interest in Moderna’s vaccine, along with the vaccines and vaccine candidates of other companies,” said Moderna President Stephen Hoge. “We also understand how important it is that large quantities of every approved vaccine be produced rapidly...and that vaccines be made available widely, transparently, and equitably.”

President Joe Biden has pledged to administer 100 million doses in his first 100 days, a goal that advisers say is achievable by administering more than one million doses a day — a mark that the country has already exceeded. The administration should aim even higher, said Energy and Commerce ranking Republican Cathy McMorris Rodgers, calling on the White House to shoot for two million every day.

Biden has also said repeatedly that every American who wants to be vaccinated should be able to by July.

Vaccine makers also discussed the rising threat of different coronavirus strains such as B.1.315, the variant first found in South Africa that appears to be less susceptible to some vaccines.

Moderna is beginning trials with the National Institutes of Health for a booster shot aimed at that strain. Pfizer is in discussions with the FDA about clinical study designs to test updated versions of its own vaccine against emerging variants, Chief Business Officer John Young said.

Novavax, which just completed U.S. trial enrollment this week for its broad Phase III trial, “is already aggressively working on a strategy to provide the broadest coverage,” said John Trizzino, chief commercial and chief business officer. He added that the company’s technology and manufacturing process make it easy to edit and scale up modified vaccines.

FDA updated its vaccine guidance just a day earlier to flesh out some of its expectations for modified or booster shots aimed at variants. While the agency’s vaccine chief Peter Marks told reporters that trials for modified vaccines could enroll a “few hundred” people — a far cry from tens of thousands enrolled in typical Phase III trials for vaccines — those particulars were not laid out in the document.

“We are hopeful that we will be able to do it without large Phase III trials,” said Hoge, who added the company has been in productive conversations with the FDA about its human trials that begin soon.

Pfizer’s Young said it would be ideal to take a flu vaccine approach with these modified shots. Vaccines for influenza are slightly altered each year to tackle new, prominent strains and do not go through lengthy Phase III trials for the changes. “Certainly we believe that more of a seasonal flu-like process, where a new variant [vaccine] might be able to demonstrate safety and immunogenicity in a smaller number of patients, might be a much quicker way of being able to expedite a new variant vaccine to patients in this country.”

The FDA did not rule out speedy modified vaccine approvals in the future, saying in the Monday guidance that “further discussions will be necessary" to decide whether the agency could at some point authorize modified Covid-19 vaccines "without the need for clinical studies."

In the meantime, House lawmakers peppered the vaccine manufacturers with questions about any potential barriers to delivering hundreds of millions of shots this year. The executives, while praising federal efforts to secure supplies, appeared hesitant to see the Biden administration invoke the Defense Production Act to procure more supplies from other U.S. manufacturers or even broaden vaccine production itself.

The law, which allows the federal government to mobilize production in various American plants, was helpful to secure specific materials early on, like lipids essential to Pfizer’s vaccine formula, Young said. But Pfizer has since moved lipid production in-house and is confident about its supplies. “DPA is certainly very useful,” but is “something to be used to address specific problems rather than generally,” he said.

Hoge pointed out that vaccine production is a complicated process employing not just raw materials but specific manufacturing infrastructure and highly skilled laborers. “Our challenge is any time we want to bring more capacity online, we have to line all that capacity up and it takes four, six maybe nine months,” he said, questioning whether that timeline is useful. “Looking forward, that’s really a question for the U.S. government to answer.”

Rachel Roubein contributed to this report.