Optimism exists for two safe and highly effective vaccines that could soon be authorized by the Food and Drug Administration from pharmaceutical companies Pfizer and Maderna, Operation Warp Speed officials said today in a press conference.
In an announcement Monday from the independent data and safety monitoring board for Moderna’s candidate vaccine, it showed about 95% efficacy, they said.
A panel of Operation Warp Speed officials met in Washington, D.C. today to give reporters an update on the vaccine. They are Army Gen. Gustave F. Perna, chief operations officer for Operation Warp Speed; Health and Human Services Secretary Alex M. Azar II; and Dr. Moncef Slaoui, chief advisor for OWS.
“We’ve worked closely with these manufacturers to ensure that they have what they need in the way of raw materials with Operation Warp Speed, applying the same skills and that keep the U.S. military supply to ensure that there are no delays in vaccine production,” Azar said.
Because of this work, Azar said by the end of December, about 40-million doses of these two vaccines are expected to be available for distribution, pending FDA authorization, he said. And that’s enough to vaccinate about 20 million of the most vulnerable Americans, he added.
“Production, of course, would continue to ramp up after that,” Azar said, adding, “We’ve been laying the groundwork for distribution and administration for months.”
The HHS secretary said there are four major tasks necessary to get the manufactured product to Americans safely to save lives: allocation, distribution, administration and ongoing monitoring and data work.
“We’ve learned much of the groundwork for these efforts and covered the major costs,” he said. “We’ve paid for the vaccines. We’ve worked to ensure that [administrative] costs will be covered by private insurers and the federal government through Medicare, Medicaid and our program to cover COVID-19 costs for the uninsured.”
Azar emphasized no American will face an out-of-pocket cost for getting a COVID-19 vaccine.
“We’ve procured ancillary supplies like needles and personal protective equipment and assembled them into kits that we will pair up with vaccine supplies as they’re distributed. This overall task is a partnership between the federal government [agencies] including Operation Warp Speed and the [Centers for Disease Control and Prevention] and the 64 state, local and territorial public health jurisdictions that the CDC works with on public immunization programs,” he said.
Last week, OWS reached nationwide agreements to allow administration of the vaccine by pharmacy chains and networks of independent pharmacies to cover more than 60% of the pharmacies across the country, Azar said, adding that people are still encouraged to wash their hands and keep a safe social distance from others.
Slaoui said OWS officials are very pleased with the progress made in less than 10 months after the pandemic began.
In addition to the development of the two vaccines that are showing efficacy of about 95%, two more vaccines are also showing promise, he said.
“We are working with the FDA and the CDC to set up together a very, very high performance, active pharmacovigilance system that resembles almost to the day the assessment that we do in clinical trials to look at the safety of the vaccines in the population, as the vaccine immunization is rolled out later in December — if the vaccines are approved — and these data will be analyzed on a [day-by-day] basis,” Slaoui said.
“We’re going to take a whole-of-America approach, Perna said, adding that it’s the collective group that will make this successful. Distribution of the vaccine will be based on fair and equitable availability of the vaccine pro rata to the population, he noted.
Collaboration and planning with national chain pharmacies CVS and Walgreens has been done, Perna said.
“We’re bringing this whole-of-America approach from government to industry, and we’re bringing it all together to ensure that safe and effective vaccines are delivered to the American people in a timely manner,” Perna said. “[As for] the time associated with delivery, we will begin distribution of the vaccine within 24 hours after an emergency-use authorization is approved, and only after the science has determined and approved it accordingly. Then we are poised and ready to begin distribution.”