USA

"No shortcuts" taken on COVID vaccine safety, top official says

"CBS This Morning" explores whether America is ready for a coronavirus vaccine in a special three-part series, Road to a Vaccine. Watch part one here and part two here.

Operation Warp Speed, the Trump administration's unprecedented effort to accelerate production and distribution of a coronavirus vaccine, is already producing tens of millions of vaccine doses, even before any vaccine candidate has been proven safe and effective.

The nearly $10 billion program's stated goal is to produce and deliver 300 million doses of safe and effective COVID-19 vaccines to Americans, with the initial doses available by January 2021. 

Retired Lieutenant General Paul Ostrowski, director for supply, production and distribution of Operation Warp Speed, said they are "absolutely" on track to achieve that goal. 

"We are actually going to exceed that expectation," Ostrowski told CBS News senior medical correspondent Dr. Tara Narula. "We will have vaccines, we anticipate, prior to the turn of the new year."

But there won't be 300 million doses prior to the new year, Ostrowski said.

"We will start off with lower amounts and, over time, gradually build to that," he said.

Asked when the general population should expect to be able to get a vaccine, Ostrowski said, "It will probably be a prioritization-based schedule."

"We would expect, that by the first quarter, end of first quarter, early second quarter of next year," he said.

The accelerated timeline of Operation Warp Speed has some Americans concerned about safety. But, Ostrowski said safety is not being compromised.

"We've gone through the same trial process as any other drug or vaccine ever has," he said. "And the amount of FDA oversight and the approval process with the FDA is just like any other drug or any other vaccine."

"It is unprecedented with respect to the speed," he said. "We are taking absolutely, positively no shortcuts with respect to safety or efficacy."

One of the challenges Ostrowski foresees in getting a vaccine to Americans is the storage, he said. 

"At least one of them is a cold-chain vaccine," he said. "It has to be kept fairly cold, and we're working with that particular pharmaceutical company in order to get further studies as to how long it can be frozen and how long it can stay in a refrigerator or how long it can be at room temperature."

Ostrowski said the vaccine will be free for Americans.

"The government has already bought the vaccines, and the government has already paid for the distribution of the vaccines," he said.

But the trade association that represents state immunization managers has asked Congress for $8.4 billion to help distribute the vaccine. Asked if states will receive sufficient federal funds, Ostrowski said they would. 

"We've already distributed 200 million," he said. "Another 140 will be passed out soon, as we've got these plans now back from the states, and we understand what their challenges are and what they need."

Early in the pandemic there was a shortage of personal protective equipment and testing supplies, but Ostrowski said the distribution of a vaccine will go more smoothly.

"We've got billions of needles, billions of syringes, here in the United States, that we are putting together in kits," he said. "And we are going to ship those kits, in addition to the vaccines, to an administration site."

The Trump administration has compared Operation Warp Speed's program to the notoriously secret government project to make the first atomic bomb, the Manhattan Project.

Responding to critics who say the program may not be transparent, Ostrowski said, "We have been as transparent as we possibly can."

"We have to come together, as a whole-of-America approach with our industry partners, and get after the hard things, looking at, what are the key factors wearing on the problem?" he said. "So what we're trying to do now is become a lot more transparent with respect to where we're at. Because frankly, now, we have a plan. And we feel good about our plans."

The lieutenant general urged Americans to trust and take the vaccine. He also said he expects Operation Warp Speed's distribution plan to remain the same regardless of who wins the presidential election in November.

Football news:

Mijatovic on Real Madrid's loss: Zidane must improve. The team didn't know Alaves' strengths
Frank Lampard: I Respect Mourinho. There will be no results like his if you are not a talented coach
Coutinho on Bayern: Winning the Champions League has always been my big goal. Now I want to take it with Barca
Real Madrid believe that the pressure on the referees affected the work of the referees in the match with Alaves
Lineker about VAR: I was wrong to be a supporter of it. Sport has not changed for the better
Mourinho before the match with Chelsea: Tottenham are not afraid of anyone
Guardiola on the schedule: Players lose the joy of football. This is a problem