The director of the National Institutes of Health (NIH) said despite the images admired by Operation Warp Speed - the Trump administration’s attempt to deliver a COVID-19 vaccine as soon as possible – the federal government takes all necessary precautionary measures for security.
In a broad interview Wednesday, NIH chief Francis Collins said he was optimistic about the potential for one or more vaccine candidates to make it through phase three trials by the end of the year, and that the Trump administration is making additional plans to to deliver that vaccine broadly.
He promised that the government’s top scientists would not be bothered with approving a vaccine before a candidate both proves that it produces a strong immune response and that it does not come with harmful side effects.
“I think we’re on a very solid track in the United States, but there are obviously a lot of scientific uncertainties that we need to look into,” Collins said.
“I think there is reason to be cautiously optimistic that by the end of 2020 we will have at least one and perhaps more than one vaccine that has been assessed by strict standards to be safe and effective,” he added.
Collins is among the public health experts who do not like the image transmitted by Operation Warp Speed of the White House.
He said that while the administration was moving quickly to lay the groundwork for providing multiple candidates for faxes, scientists should not skip the health and safety steps in striving for a solution.
‘I know there is some concern because of this warp speed label that there may be corners cut that should not be. I want to trust you and everyone else that we will not allow this, ‘he said.
The vaccines entering phase three trials will enroll 30,000 people in areas where the virus is spreading rapidly, half of whom will receive a vaccine and half of whom will receive a placebo. The studies will be overseen by data security supervisors, the only participants who will know who received a fax and who did not.
Those boards will have the authority to stop a trial if security issues arise when serious side effects appear. They can also speed up the timeline as early data show substantial evidence that a vaccine is working properly.
“Everything is a designed strategy that is characterized as the strictest way to find out if something is working and if it is safe, and that will absolutely be applied in this circumstance and there will be no approval of a fax that does not go through that high, high standards, ”Collins said.
The upcoming election has slammed the U.S. response to the pandemic in sharp partisan terms, but Collins said he feels no pressure to approve a fax in a way that fits a political calendar. Instead, he said, comes the pressure from the number of Americans who have become significantly ill, and the more than 160,000 who have died.
“I feel great pressure to rage science because people are dying. I do not feel any pressure at all about a political time trial, ‘he said. “I’m intolerant of anyone who tells me we should take longer to do something than I think it should take, and I think every day about ways we might be able to shorten steps that may be a little more bureaucratic than they need to be. to be. “
“But I have absolutely no interest in an argument about how this effort should conform to some political scheme,” he added. “If it is going to have the confidence of the public and if it is going to have the scientific rigor behind it, we should only go by those criteria.”
Collins, 70, has led the NIH since 2009. A geneticist leading the Human Genome Project, he has received both the National Medal of Science and the Presidential Medal of Freedom.
Now, as a member of the White House coronavirus task force, he regularly brings in Vice President Pence and discusses the models and materials produced by Deborah Birx
Deborah BirxIt’s our fault ‘the monster’ virus is everywhere Massachusetts governor pauses again, again impresses what coronavirus restrictions Birx warns of uptick in cases of coronavirus in 9 cities MORE, the State Department’s adviser oversees the administration’s COVID-19 response.
The numbers he has seen lately are not good, especially per person death that puts the United States behind almost every other country in the world, with the exception of the United Kingdom, Chile and Peru.
“I’m really looking much closer at what happened to our mortality rate in the United States as a function of our total population, and that’s still very difficult,” Collins said. “We are still losing 1,000 or more per day, which is more than it was six weeks ago.”
Collins said he was concerned about Russia’s announcement this week that it had approved a vaccine candidate without going through phase two and phase three trials that would follow a more scientifically rigorous country. That he skips, he said, puts Russians in danger – something he does not do to Americans.
“I think what they have decided to do is to skip phase two and phase three safety and effectiveness tests is a very risky step forward,” he said. “They therefore propose to potentially immunize millions of people with the vaccine without having the data to know whether it will be effective enough to protect against COVID-19.”
“I think the global community is responding with concern about whether they are endangering their people,” Collins added. “I think some bad wag called this Russian roulette.”
Eight vaccine candidates are in phase three trials around the world. The NIH has helped develop a messenger candidate based on messenger RNA with pharmaceutical giant Moderna, and this week the government agreed to pay the US company $ 1.5 billion for 100 million doses if the vaccine proves effective and safe.
The Trump administration has also agreed to take delivery of 100 million doses of a candidate developed by the German company BioNTech and the New York-based Pfizer.
Other Phase Three candidates are in trials in Argentina, Australia, Brazil, China, Germany, India, Indonesia, Saudi Arabia, South Africa, the United Arab Emirates and the United Kingdom.
Following the necessary steps and demonstrating the safety of a drug will be essential to building confidence in the United States, Collins said, as a troublesome movement of anti-vaccination activists has become increasingly vocal, although its numbers remain relatively small.
‘The best hope we have that we are moving in the rearview mirror is a vaccine that humans are willing to take so that we can, in essence, reduce the chance of transmission and eradicate this disease by providing enough herd immunity . But if half the nation says, ‘No, I do not want this vaccine,’ then this coronavirus pandemic could go on and on, to the great detriment of our country, endangering vulnerable people, “he said.
‘I’m surprised, to be honest, that opposition to this vaccine has reached the level it has. I thought when people saw the terrible tragedies and suffering that surrounds us from this disease, that maybe some of the resistance we have seen against other vaccines for children would not be cut short. ” “But at the moment it seems to be quite prominent.”
Even without the anti-vaccine movement, fewer Americans are looking for vaccines that are readily available. Less than half of the U.S. population received a flu shot last year.
With the annual flu season looming, public health experts are worried about the stress on health systems that will come when a flood of sick people appears with present symptoms that could be affected like COVID-19. The NIH is working on a program called the RADx, as the rapid acceleration of diagnostics, to develop one test that will screen for both diseases.
“It will be a terrible stress on our medical care system if we have both a lot of impact and a lot of COVID-19 present with very similar symptoms all at once,” Collins said.
But Collins said there are some signs the flu season may be milder than normal. These signs are based on early evidence from the southern hemisphere, where the flu season is already underway, and because the social distance techniques needed to combat COVID-19 are also effective in stopping flu transport.
Collins said he talks to him regularly Anthony Fauci
Anthony FauciFauci defends vote by mail as ‘you do not want to take the chance’ in person Museum unveils new Fauci bobbleheads after previous edition sold out Marlee Matlin: ‘Unfathomable’ that White House does not have sign languages at coronavirus introductions MORE, a fellow member of the White House Coronavirus Task Force that runs the National Institute of Allergy and Infectious Diseases within the NIH, on the threat of the flu.
But he was hesitant to criticize Fauci’s recent appearance on the mound for throwing out the first pitch at opening time for the Washington Nationals, a pitch that ran well off the mark.
“Well, he threw it on purpose because he did not want anyone to catch anything,” joked Collins. ‘It was a good excitement anyway. The shape looked pretty good. The goal? Well, OK, I probably would have done less, so I will not cast a shadow in his direction. ”
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