Trump's vaccine chief says he would resign if there was undue interference in Covid-19 vaccine process

President Donald Trump listens as Moncef Slaoui, the former head of GlaxoSmithKlines vaccines division, speaks about coronavirus vaccine development in the Rose Garden of the White House on May 15, in Washington. Drew Angerer/Getty Images

Moncef Slaoui, the chief adviser to Operation Warp Speed, said in an interview with Science that he would resign from his role if there was undue interference in the Covid-19 vaccine effort.

“I have to say there has been absolutely no interference,” Slaoui said. “Despite my past, which is still my present, I am still the same person with the same values. The pandemic is much bigger than that. Before being a political person with convictions, humanity has always been my objective.” 

When asked if he and the Trump administration had discussed waiting to ask for an emergency use authorization until after Election Day, Slaoui said an EUA should be requested when it has evidence of safety and efficacy.

“I have to say, maybe even despite my personal political views, that I don't think that's right, because 1,000 people die every day [from COVID-19],” Slaoui said. “If a vaccine [had evidence of safety and efficacy] on 25 October, it should be [requested] on 25 October. If it's 17 November, it should be 17 November. If it's 31 December, it should be 31 December," he said.

“It needs to be absolutely shielded from the politics,” he said. “I cannot control what people say. The President says things, other people will say things. Trust me, there will be no EUA filed if it’s not right.” 

CNN chief medical correspondent Dr. Sanjay Gupta said the US response to coronavirus is “shocking,” as a new model often cited by health experts predicts more than 400,000 Americans could die from Covid-19 by January 1. 

The model from the University of Washington's Institute for Health Metrics and Evaluation would mean an additional 224,000 Americans lost in the next four months — more than double the 186,000 deaths reported to date by Johns Hopkins University.

Gupta said on CNN’s “New Day” that he spoke with Dr. Anthony Fauci about this new model and said he expressed “a convergence of frustration.”

Gupta said he’s also “discouraged and frustrated” by Americans’ lax reaction as the coronavirus continues and said he’s been up all night thinking about the models.  

“What I'm starting to feel is the existential threat is the human behavior. … I think we really are having a reckoning with regard to just basic human decency at this point,” he added. 

Gupta said the virus is not hard to combat, as long as people wear a mask, wash their hands, keep their distance and spend time together outside — and it’s even more important going into the fall and winter. 

“This is not that hard. We take brain tumors out of people. We treat what are considered untreatable cancers. We put people back together after massive trauma. This is not that hard,” Gupta said. 

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The World Health Organization is “not expecting to see widespread vaccination [for coronavirus] until the middle of next year," spokesperson Margaret Harris told reporters in Geneva Friday.

There are currently 34 vaccines globally carrying out human trials, according to WHO, with 142 vaccine candidates currently in the pre-clinical trial phase.

Harris was speaking the same day that the first peer-reviewed results of phase one and phase two clinical trials of Russia’s coronavirus vaccine – the world's first approved coronavirus vaccine for public use — were published in the prestigious medical journal The Lancet.

Although Harris did not reference the Russian vaccine, Harris emphasized the importance of safety and efficiency checks saying that phase three trials “will take much longer” in order to “see how truly protective” and safe any vaccine is.

Remember: Scientists not involved in the study of the Russia vaccine said while the results are a positive sign, only larger, phase three trials can confirm whether the vaccine actually prevents illness with Covid-19. 

Georgia Governor Brian Kemp puts on a mask after speaking at a press conference announcing statewide expanded COVID testing on August 10, in Atlanta. Elijah Nouvelage/Getty Images

Georgia Gov. Brian Kemp is urging all residents not to let their guards down and to follow all public health guidelines over the Labor Day weekend. 

Kemp said that although the state is starting to see a decline in Covid-19 cases and hospitalizations, it is important for everyone to follow and enforce the guidelines outlined in the governor's executive order. This includes a ban on large gatherings and safety measures on businesses and restaurants as well as a shelter in place for the medically fragile.

Iraq reported at least 5,036 new cases of Covid-19 in the past 24 hours, which is the highest daily number of infections recorded since the beginning of the pandemic, the country's Ministry of Public Health said.

The latest recorded cases brings the country's total case count to 252,075. There were also 84 new deaths recorded in the last 24 hours, raising the national death toll to 7,359, the Ministry says.

Another 1.4 million jobs were added to the US economy in August, as the jobs recovery continued to slow.

This was in line with expectations, and down from 1.7 million jobs added in July and 4.8 million in June.

Every person who can go back to work is a win for the recovery from the unprecedented jobless crisis the Covid-19 pandemic has brought on. However, America is still down 11.5 million jobs from February.

The unemployment rate fell to 8.4%. It's below 10% — which was also its Great Recession peak — for the first time since March.

This means millions of families in need of benefits to make ends meet while Congress continues to argue about the next stimulus package.

During the Republican National Convention last week, President Trump promised to create 10 million new jobs in 10 months. If the predictions hold true, he'll have 8.6 million more to go — and even then, the US economy wouldn't have gained back all the jobs lost since February.

Trump's promise could prove difficult to achieve. The recovery is losing steam as the sugar rush from stimulus wears off, millions of people are still working from home, and retail, restaurants and other services industries remain battered from the pandemic.

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Lexie Brown, a business major at Indiana University, attends an online class on the lawn of her Alpha Omicron Pi sorority house to distance from other house residents. Over 30 Greek houses at Indiana University are currently under quarantine. Jeremy Hogan/SOPA Images/AP

Indiana University Bloomington is now recommending that all students living in sorority and fraternity houses reevaluate their living situations due to the quickly increasing spread of coronavirus in those environments. 

Greek houses are owned and operated by their respective Greek organizations, not by the university as self, so IU doesn’t have the jurisdiction to regulate the houses.

CNN previously reported that 30 fraternity and sorority houses at the school had been placed under quarantine by the county health department. 

A Covid-19 vaccine developed and tested in Russia generated neutralizing antibodies in dozens of study subjects, and while the vaccine often caused side effects such as fever, those side effects were mostly mild, according to data published Friday in the medical journal The Lancet. 

In the phase one and two studies, all 76 study participants developed antibodies to the virus that causes Covid-19, according to the report. 

The levels of neutralizing antibody response were similar to the immune response that people had after naturally recovering from Covid-19, according to the study.  

The researchers also looked at responses from T cells, another component of the immune system. 

“[Outcomes from] the trial also suggest the vaccines also produce a T cell response within 28 days,” the researchers wrote. 

Remember: Scientists not involved in the study said while the results are a positive sign, only larger, phase three trials can confirm whether the vaccine actually prevents illness with Covid-19. 

“The data on the Russian vaccine studies reported in the Lancet are encouraging,” said Brendan Wren, professor of microbial pathogenesis, London School of Hygiene and Tropical Medicine.  

In the study, half of the participants developed fevers and 42% developed headaches. In addition, about 28% experienced weakness and 24% had joint pain. 

The article did not say how long these side effects lasted but said “most adverse events were mild.” 

The vaccine was registered in Russia in August, before it had gone through large-scale trials. The researchers at the Gamaleya National Research Centre for Epidemiology and Microbiology in Russia received approval on August 26 to do a phase three trial, which is expected to have 40,000 volunteers, according to a press release from The Lancet. The researchers are already distributing the vaccine to high-risk groups, according to Kirill Dmietriev, head of the Russian Direct Investment Fund (RDIF), which is financing Russian vaccine research. 

Gamaleya is using adenoviruses in their Covid-19 vaccines; this is the same type of approach used in the vaccine developed by University of Oxford and AstraZeneca. The adenovirus delivers genetic material for the spike protein that sits atop the virus the causes Covid-19, and that genetic material is designed to generate an immune response to the virus that causes Covid-19.

Adenoviruses can cause a variety of symptoms, including the common cold. The researchers manipulate the virus so it will not replicate and cause illness. 

The Gamaleya vaccine is given in two doses, and each dose used a different adenovirus vector. 

“Using two different viruses gives a theoretical advantage,” said Dr. Paul Offit, a vaccinologist at the University of Pennsylvania.

Employees are seen at Russia's biotech company BIOCAD, which is working on a coronavirus vaccine. Olga Maltseva/AFP/Getty Images

The first peer-reviewed results of Phase 1 and Phase 2 clinical trials of Russia’s coronavirus vaccine, which is named Sputnik-V, have been published in the medical journal The Lancet on Friday.

Results from the two 42-day trials – which each included 38 healthy adults – “have a good safety profile with no serious adverse events” among participants, The Lancet said in a press release, noting that the vaccine-induced antibody responses in all participants.

Russia faced criticism last month when it announced the world's first approved coronavirus vaccine for public use, even before Phase 3 trials are completed. 

Russia also faced skepticism over how quickly the vaccine was registered and the initial lack of scientific data around the clinical trials. 

Naor Bar-Zeev, deputy director of the International Vaccine Access Center at Johns Hopkins University said in a linked comment that the studies are “encouraging but small,” according to The Lancet. Bar-Zeev was not involved in the Russian study, but peer reviewed it.

Kirill Dmitriev, CEO of the Russian Direct Investment Fund (RDIF) funding the vaccine development said the trial results confirm the "high safety and efficacy" of the vaccine, adding in a statement Friday that the results are "a powerful response to sceptics who unreasonably criticized the Russian vaccine."