Daines, FDA official optimistic about COVID-19 drug rollout

U.S. Sen Steve Daines, R-Mont., told Montana health professionals Wednesday he’s optimistic a COVID-19 vaccine will be ready for distribution by year’s end, in part because the government will pay for manufacturing of promising drugs ahead of final approval.

The senator was joined on the Zoom conference Wednesday by Dr. Anand Shah, the Food and Drug Administration’s deputy commissioner for medical and scientific affairs.

“I’ve always felt, and still firmly believe, the only way our country is going to get back to a sense of normal, and fully get back to work and restore confidence in our economy is to stop the pandemic,” Daines said. “And that will be by delivering a COVID-19 vaccine and therapeutic drugs, which is exactly why this is a top priority of mine today and has been since the start of the pandemic.”

Daines is a former Proctor and Gamble employee involved in launching FDA regulated products. Through that experience, he was aware of how long it can take to get a drug to market because typically drug production doesn’t start until after FDA approval. An alternative approach is to begin manufacturing drugs as soon as they seem highly likely to be approved.

Dual tracking, the process of having drugs made and ready to distribute on the first day of FDA approval, seemed worthwhile, Daines said. In March, he proposed adding $10 billion to the Coronavirus Aid, Relief, and Economic Security Act, or CARES Act, which Congress did.

“American science, including right in Montana, the University of Montana, there’s development going on to accelerate and complete late stage development of a COVID-19 vaccine and establish large-scale manufacturing, which can deliver 300 million doses of a vaccine, with the first doses being delivered as early as sometime this year,” Daines said. “Especially as we’ve seen an uptick in cases and sadly more deaths in Montana and nationwide.”

Shah said COVID-19 vaccines and treatments will get to market six months earlier than normal because of federal spending on dual tracking. He started his comments by recognizing the sharp increase in COVID-19 cases in Montana and the 13 deaths over the past two weeks at Canyon Creek Memory Care Center in Billings.

“I want to be very clear that we will not compromise the safety standards to approve a vaccine,” Shah said. There are currently no approved drugs made specifically for treating COVID-19, but FDA has created a program to accelerate development of treatment therapies. Shah said there are 144 active clinical trials for COVID-19 treatments being monitored by the FDA, plus another 450 treatments in the planning stages for development.

The first treatment to emerge from the program, remdesivir, was granted emergency authorization for use under certain circumstances, while continuing though the approval process. The FDA shipped 960 doses of remdesivir to Montana this week, enough of the drug for 153 treatments, each one dosed out over a week to patients sick enough with COVID-19 to be hospitalized.

U.S. Health and Human Services announced in late June that the federal government had secured the first 500,000 doses of remdesivir, enough for 94,200 treatments, and that hospitals would be charged no more than drug manufacturer Gillead Science’s wholesale acquisition price of $3,200 a treatment. Federally funded dual tracking was used to get the drug to market early.

The United States has first dibs on the drug until the end of September.

The rush for COVID-19 treatments and vaccines has brought attention to the long-trending exit of drug manufacturing in the United States. Shah said FDA manufacturing programs are focused on promoting drug production in the U.S.

At the University of Montana Center for Transitional Medicine, researchers are working on ways to make COVID-19 vaccine doses more effective and making the immune response longer and more durable.

“We have a pretty large team here at the University of Montana. We have about 50 people now working on vaccines and the COVID is one of those programs,” said Director Jay Evans.

Medical professionals participating in the meeting wanted to know how it would be decided who received a COVID-19 vaccine first, the preference being to protect medical workers interacting with COVID-19 patients daily.

Throughout the meeting, Daines and Shah emphasized that vaccines would still have to go through all three phases of drug trials and that no corners would be cut.

The discussion took place on the same day the federal government placed a $1.95 billion order for 100 million doses of a COVID-19 vaccine being developed by Pfizer. A day earlier Pfizer and three other drug companies told a House committee that they expected to turn a profit on their vaccines. Of the four, only Pfizer hadn’t accepted federal funding for its vaccine development.

Daines is up for election this November and faces a tough challenge from Montana Gov. Steve Bullock, a Democrat.