Pfizer has already made “several hundred thousand doses” of a potential coronavirus vaccine as it prepares to seek emergency use in the US by November.
The drugmaker told the Mail on Sunday that scientists in its main British lab have also unearthed drugs that could provide a potential complete cure for COVID-19, as opposed to merely a preventative vaccine.
The firm’s UK boss, Ben Osborn, said the company is manufacturing the huge stockpile of its current vaccine candidate in Belgium “at risk and at scale,” calling it “tremendously exciting.”
“It was great to see the first vial coming off the manufacturing line. It just brought a tremendous smile to my face to see all of this work actually result in a product,” he said.
But “we can only go as fast as the science allows us to,” he stressed.
Pfizer expects to know whether the vaccine works by the end of this month, but the company still has to prove the shot is safe and can be manufactured properly to seek a so-called emergency use authorization, CEO Albert Bourla said Friday.
If it’s safe, he expects his company to seek emergency use in the US in the third week of November.
“We are operating at the speed of science,” he said.
State public health departments say they’re ready to leap into action as soon as a COVID-19 vaccine is approved but caution so many things are still unknown that exactly what that leap looks like is hard to say right now.
For Dr. Nirav Shah, director of the Maine Center for Disease Control and Prevention, it's like planning an outdoor picnic for 1.3 million of his closest friends (the population of Maine) without knowing how much food he has, who's coming, how he's going to invite them and what they can and can't eat.
"We plan for things we have knowledge around and move forward from there," he said.
The good news is that the earliest date a vaccine is expected to arrive is now around Thanksgiving so that gives states a little breathing room. There had been the possibility that a vaccine could become available as soon as Nov. 1.
To get ready, in Maine the public health department is planning "down to the person," Shah said. "We're looking at how many miles our public health nurses may need to drive."
On Friday state public health departments submitted vaccination distribution plans to the U.S. Centers for Disease Control. The plans were as detailed as they could be given the many things that are still unknown:
- When a vaccine or vaccines will become available.
- Which groups will be first in line to get it and who comes next.
- What kind of storage and refrigerator or freezer requirements they might have. At least one must be stored at -94°.
- For vaccines that require two doses (all but one), when the second dose must be administered.
- Information about whether a certain vaccine works or doesn't work in specific populations such as the elderly, pregnant women or the young.
In a call with reporters Monday, public health officials talked about how they're preparing and what they still need.
This involves hours and hours of meetings: Last week state health officials spent two hours meeting with Pfizer just about the packaging it has developed to keep the vaccine cold as it's distributed and stored, said Claire Hannan, executive director of the Association of Immunization Managers.
Maine's Shah said he's having multiple meetings every day and many at night to get ready for what will be one of the biggest public health pushes of the modern era.
The final plan for who gets COVID-19 vaccine first will come from the CDC's Advisory Committee on Immunization Practices. That committee is standing ready to meet the day or the day after a vaccine is approved, Shah said.
But even without the official plan, state health officials have a pretty good idea of the distribution order based on a report released earlier this month by the National Academies of Sciences, Engineering and Medicine.
The first phase, 1a, is very likely to be front-line health care workers. That will make it relatively easy because those vaccinations will take place at hospitals, which are already set up for doing large-scale vaccination efforts, Shah said.
It's when things get to the early stages of Phase 2, which includes people with preexisting conditions that put them at greater risk for becoming seriously ill or dying of COVID that it gets more complicated.
Maine has an older population and many people with preexisting conditions. "That's a large swath of Maine's population," Shah said.
There's also a complex and delicate computer interface to create. All states have immunization registries to track childhood immunizations. Those are now being expanded to include COVID-19 vaccines.
And states are building systems to remind patients to come back for their second shot, if one is needed, and which of the possible multiple vaccines they received so they know which one to get a second time.
Also at issue: Maintaining patient privacy at a faster pace than usual – recording vaccinations within 24 hours instead of five days.
"We've been telling our providers they're going to need to be reporting into our system every night," Shah said. The state's pressure-testing its systems to make sure they can handle the influx of information.
In Mississippi, state health officials have been working hard to get ready, said Dr. Thomas Dobbs, the state health officer.
"This is going to be a Herculean effort," he said.
