Limited Access
Operation Warp Speed seeks to do what’s never been done before: research, develop and produce a vaccine for a new virus in months. It’s a monumental, risky undertaking that will probably result in billions of dollars of waste, but could shave years off of typical development timelines. But even if it’s successful, warp speed will move faster for some people than others. Two other key government officials described a gradually widening trickle of access over months and months, not the sudden, widespread availability of a vaccine.

During an Aug. 7 presentation to a panel of experts convened by the National Academy of Medicine, which is helping decide who will be first in line for a shot, Operation Warp Speed chief adviser Moncef Slaoui said significant production ramp-up should start in November. It will continue accelerating over the following months until it is producing a "very large number of doses" on a monthly basis in the second quarter of 2021, Slaoui said.

Along with $8 billion in U.S. funds granted for vaccine development and manufacturing through Warp Speed, the Health and Defense departments have doled out contracts totaling almost $500 million to increase domestic manufacturing of vials and prefilled syringes for Covid-19 vaccines. The consulting company Deloitte also has a $15 million contract to track vaccine distribution and administration. The firm didn’t respond to a request for comment.

On July 27, National Institutes of Health Director Francis Collins warned that the first round of vaccines will be carefully allocated.

“There will be tens of millions of doses at the time that the first vaccine gets approved,” Collins said. “It won't be enough for everybody, and so decisions will have to be made about priorities.”

Vaccine trials typically require tens of thousands of patients and months of follow up to show they're safe enough to give to healthy people. A lack of long-term data could limit access until health officials can better assess any risks.

Moderna’s trial has signed up about 10% of the 30,000 people it aims to enroll, Fauci said on Aug. 6. Trial participants need to get the shots, which are spaced apart, and then be monitored to find out if they get infected or have any side effects.

By the early fall, the FDA may only have a few weeks of data. That may be enough to give the shot to health-care and other front-line workers and other groups at higher risk from the virus, but it almost certainly won’t be enough for lower-risk people.

That data won’t come until next year, said Geoffrey Porges, an analyst at SVB Leerink, in a July 20 note to clients.

The first announcement of federal clearance for a vaccine will more likely become a political event “with the reality of the availability, effectiveness and utility of the vaccine falling far short of the promotion by government officials,” he said.