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Another federal official raises questions about Trump’s vaccination schedule



Trump, however, has projected optimism for a faster timeline.

“”[It’s] This will happen in a very short time – it could even be in October, “the President said at a press conference on Monday.” We’ll have the vaccine soon, maybe before a special date. You know what date I’m talking about. ”

On August 6, Trump said he was “optimistic” that a vaccine would be ready by November 3.

A coronavirus vaccine by election day?  Probably not.  Here's why

“I think we will certainly have the vaccine before the end of the year, but around that date, yes. I think so,” said Trump.

And at a rally last week he said, “It will be delivered before the end of the year, in my opinion, but it could even be delivered before the end of October.”

The federal official is not the first to be skeptical of Trump’s forecast.

It is “extremely unlikely, but not impossible,” that a Covid-19 vaccine could be approved for an emergency by the U.S. Food and Drug Administration before the end of October, Moncef Slaoui, Operation Warp Speed’s chief advisor, told NPR last week.

Dr. Larry Corey, who leads a group created by the National Institutes of Health to work on coronavirus vaccines, also said he doesn’t think a vaccine will be available until election day.

“I would agree with Dr. Slaoui. The chances are very slim, very slim,” said Corey, who heads the COVID-19 prevention network.

Why we probably won’t have a vaccine by election day

In a word, that’s why there probably won’t be a vaccine before Election Day: biology.

Here's how Trump could outsmart the FDA and get a vaccine out before science

This is how the experiments work: They take 30,000 people, give half a vaccine and half a placebo, a shot of saline that does nothing. Then these 30,000 people go about their lives and you wait to see how many in each group get infected and sick with Covid-19, the “end point” in medical parlance.

This wait takes time, especially since the coronavirus vaccines currently being studied in the United States are two-dose vaccines, with each dose several weeks apart.

Vaccine manufacturers try to reach locations and populations that get them to their endpoint quickly, but it doesn’t always work.

“It all depends on how quickly the number of cases comes up and then the number of cases in each group,” wrote Dr. Robert Frenck, director of the vaccine research center at Cincinnati Children’s Hospital, in an email to CNN. “It’s REALLY a numbers game.”

The length of this waiting period depends on how likely it is that the study participants will come into contact with the virus in their daily lives. Have the trials recruited people to work from home wearing religious masks in public? In this case, it may take longer for them to be infected in significant numbers.

CDC documents say states should prepare to distribute Covid-19 vaccines as early as late October
“Who’s on the exams – the kind of people who tend to stay home or the kind of people who attended the Sturgis rally?” said John Moore, an immunologist at Weill Cornell Medicine, referring to a motorcycle rally in South Dakota that resulted in at least dozen cases of Covid-19.

Historical precedents, as well as the demographics of participants in the current studies on coronavirus vaccines, are more indicative of the type of stay at home.

This is not a good sign that the processes will complete quickly.

Why college white women are bad at studying coronavirus vaccines

Typically, clinical trial volunteers tend to be “white college graduates,” said Frenck, who served as principal investigator on dozen of clinical vaccine trials and served on the Data and Safety Monitoring Board for many others.

All three factors are potentially bad news for the coronavirus clinical trials, as data suggests that college-graded white women are at lower risk of exposure to the novel coronavirus.

In the clinical trials run by both Pfizer and Moderna, about three-quarters of the participants are white, according to the two companies.
There is a legitimate way to end coronavirus vaccine trials early, says Fauci
Whites are more likely to work from home, according to the US Bureau of Labor Statistics. Additionally, essential workers are at high risk of contracting Covid-19, and while 60% of the population is white, they make up only 55% of the essential workforce, according to the Economic Policy Institute.

These factors explain why whites are less likely than others to develop Covid-19.

While they make up 60% of the US population, whites make up only 41% of US cases for which racial information was available, according to the US Centers for Disease Control and Prevention.

Moderna and Pfizer did not publish the educational status of their participants, but if it is like other studies, the volunteers will likely have a college education.

That’s bad news too.

Moderna adds minority numbers in its vaccine study, but still doesn't achieve Fauci's goal
Those with a college education are less important workers and are more likely to work from home. According to a July Gallup survey, they are also more likely to wear masks.

All of these factors help them stay away from the coronavirus.

As for women – that’s a third potentially bad sign of the trials.

Pfizer and Moderna did not publish a breakdown of their studies by gender. According to FDA data, 72% of clinical trial participants in 2019 were women.

In addition to being able to work from home more often, women are increasingly wearing masks in public.

Clinical trials often don’t go as fast as researchers would like. However, the Covid-19 vaccine trials are unusual because of the urgency. Researchers need the studies to capture Covid-19 cases in a timely manner so that a vaccine can hit the market and life can get back to normal.

The Labor Day health experts warned about during the coronavirus pandemic are popping up across the U.S.

Corey, who runs the COVID-19 prevention network, noted that Pfizer and Moderna were the first two coronavirus vaccine trials, both of which gave their first volunteers on July 27. AstraZeneca followed this month, and several more are set to fall later in the year.

“These are the first few attempts, and we don’t know how efficiently we will reach the defined endpoints of the attempts. Will it be a straight, easily definable line, or more like a meandering path with switchbacks? We are in uncharted waters,” said Corey.

Another infectious disease expert said researchers had to be concerned that the endpoints will be slow to come, considering who usually participates in studies.

“I can’t imagine that no one is worried that the endpoints will be a long time coming for these reasons,” said Dr. William Schaffner, an infectious disease specialist at Vanderbilt University Medical Center.

He personally knows two white women with university degrees who have volunteered for the vaccine trials with Covid-19: his daughter-in-law and his granddaughter.

“They wear masks. They distance themselves socially. They are meticulous,” said Schaffner. “The other day they came to our pool and they stayed at one end of the pool and we stayed at the other. They never went into the house. My wife said to me, ‘Well, you won’t be helpful in the experiments, that’s for sure.’ ”


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