Health

Head of Operation Warp Speed says first Americans could get vaccines within 24 HOURS of FDA approval

The chief of the Trump administration’s Operation Warp Speed said the first Americans to get coronavirus vaccines could receive them within 24 hours of emergency approval.  

Dr Moncef Slaoui leads the government’s plan to fast-track the production of 300 million vaccine doses in the US by 2021.

At an event conducted by The Washington Post, he said that healthcare workers and other groups could be vaccinated within a day or two of emergency use authorization (EUA) from the US Food and Drug Administration (FDA).   

He added that he hopes 20 million people will have been vaccinated by the end of this year.

‘Within 24 hours, maybe at most 36 to 48 hours, from the approval, the vaccine can be in people’s arms,’ Slaoui, a former GlaxoSmithKline executive, said. 

The FDA’s Vaccines and Related Biological Products Advisory Committee is meeting on 10 to discuss the vaccine submitted by Pfizer Inc, meaning the first shots could be distributed next week.

Dr Moncef Slaoui, the chief of Operation Warp Speed, said the first Americans to receive coronavirus vaccines could get them within 24 hours of FDA approval during an event hosted by The Washington Post on Tuesday (pictured)

He said he hopes to have 20 million vaccinated by the end of the year and that the US should have 60 million to 70 million doses a month by January 2021. Pictured: Slaoui (left) during an event at The Washington Post on Tuesday

He said he hopes to have 20 million vaccinated by the end of the year and that the US should have 60 million to 70 million doses a month by January 2021. Pictured: Slaoui (left) during an event at The Washington Post on Tuesday

An FDA meeting on Pfizer's vaccine (pictured) is being held on December 10 and a meeting on Moderna's vaccine is being held on December 17

An FDA meeting on Pfizer’s vaccine (pictured) is being held on December 10 and a meeting on Moderna’s vaccine is being held on December 17

Slaoui said practice shipping runs – without vaccines – have been conducted to prepare for initial distribution expected to begin in mid-December once Pfizer Inc receives an EUA for its vaccine.

Pfizer applied for the EUA on November 20 after publishing data that showed the vaccine developed with German partner BioNTech SE was 95 percent effective in preventing COVID-19.

A committee of outside expert advisers is scheduled to meet on December 10 to discuss the data and make a recommendation to the FDA on whether to grant authorization. 

The agency typically follows the advice of these expert committees.

States will be in charge of distributing vaccines to their populations. Slaoui said the federal government will ship doses to the locations identified in state plans.

The US should have 60 million to 70 million doses a month by January, between both the Pfizer and Moderna Inc vaccines, Slaoui said.

Moderna’s vaccine, which was about equally effective, was submitted for EUA with the FDA on Monday.

It will be reviewed by the expert panel on December 17, one week after Pfizer’s. 

Both vaccines require patients to receive two doses about a month apart.

On Monday, Stephen Hoge, the president of Moderna, told he is ‘quite optimistic’ the COVID-19 company’s vaccine will be approved.

‘We are quite optimistic, actually, that the vaccine is – the data speaks for itself and they’ll be supportive,’ Hoge said in a preview clip from a longer interview that will air on Dateline on Thursday.  

It comes after the former director of the CDC  said on Tuesday that getting the COVID-19 vaccine out to the public will be ‘the single most complicated vaccination program in American history.’    

Dr. Tom Frieden served as the CDC Director between 2009 and 2017 after being appointed by Obama. He appeared on Good Morning America on Tuesday

Dr. Tom Frieden served as the CDC Director between 2009 and 2017 after being appointed by Obama. He appeared on Good Morning America on Tuesday

In an appearance on Good Morning America, Dr Tom Frieden – who served as director between 2009 and 2017 – was interviewed about vaccines currently being reviewed by the FDA.  

Frieden said there will be several challenges in deciding who gets it first but that ultimately it comes down to two things; where can the most lives be saved and what is fairest. 

Frieden said nursing homes will be a priority because that is where ’40 percent of all COVID-19 deaths have been’, and that doctors and nurses will also be high on the list. 

‘You want to really focus on nursing homes. That’s where 40 percent of the deaths have been, ‘ he said.

‘In terms of fairness – doctors, nurses and all healthcare workers, not just the people you see stories about, the people cleaning floors, checking people in, who are exposed but of getting it and spreading it. 

‘This kind of public discussion and decision is a healthy way to have this prioritization done.

‘We expect approval to come pretty soon but we do expect there to be bumps in the road. 

‘When you vaccinate millions of people, some people get really sick after the vaccination and you don’t know whether that was the vaccine or just coincidence.

‘That has to be studied carefully or you’re going to get all sorts of wild rumors flying around. 

‘That’s another place where you really need transparency. 

‘There may be production problems, rumors, people who don’t want to take it… this is probably the single most complicated vaccine program in American history,’ he said. 

Freiden also said that while the news was ‘encouraging’ and approval would come ‘soon’, it is not yet on the horizon and the country is in for the ‘worst COVID season yet’ if people do not start following rules and guidelines properly.

Hospitalizations across the country surpassed 96,000 on Monday – the highest they have ever been. 

Across the board, deaths are also rising. 

The Trump administration must now work with the incoming Biden administration to facilitate the vaccine roll-out but there has not been a huge amount of dialogue between the two so far. 

HOW DO THE MODERNA AND PFIZER/BIONTECH VACCINES COMPARE? 

Moderna and Pfizer/BioNTech have both released interim results of the final stage clinical trials of their vaccines, with both suggesting they are extremely effective.

Here’s how they compare: 

PFIZER (US) & BIONTECH (DE)

mRNA vaccine – Genetic material from coronavirus is injected to trick immune system into making ‘spike’ proteins and learning how to attack them.

mRNA vaccine – both Moderna’s and Pfizer and BioNTech’s vaccines work in the same way.

94.5% effective (90 positive in placebo group, 5 positive in vaccine group) 

90% effective (estimated 86 positive in placebo group, 9 positive in vaccine group)

US has secured 100million doses for $1.525billion (£1.16bn), suggesting it will cost $15.25 (£11.57) per dose; $30.50 (£23.14) per person.

US will pay $1.95bn (£1.48bn) for the first 100m doses, suggesting a cost of $19.50 (£14.80) per dose; $39 (£29.61) per person.

Moderna will produce 20m doses this year, expected to stay in the US. 

First vaccinations expected in December.

What side effects does it cause? 

Moderna said the vaccine is ‘generally safe and well tolerated’. Most side effects were mild or moderate but included pain, fatigue and headache, which were ‘generally’ short-lived. 

Pfizer and BioNTech did not produce a breakdown of side effects but said the Data Monitoring Committee ‘has not reported any serious safety concerns’.


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