Fauci wants a global rollout of America’s ‘right on schedule’ vaccines

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Top global infectious diseases scientist and US presidential adviser Dr Anthony Fauci told doctors in South Africa during a PPS-sponsored webinar that it should be known “within weeks” if there is a safe and effective vaccine, writes Karen MacGregor for MedicalBrief. The US, as with its earlier treatment response to HIV/Aids, had a “moral obligation” to ensure that “we don’t have just rich countries getting vaccines”.

In a wide-ranging chat during which he praised SA’s pandemic containment efforts, Fauci also admitted to what he called “a deep down, non-scientifically based prejudice” regarding Vitamin D.

With the United States in advanced stages of trialling two COVID-19 candidate vaccines, Fauci told his SA audience: “I think we’re right on schedule.” Irony lurks in the circumstance of a country that appears most likely to administer a mass vaccine globally, being the same country with one of the world’s messiest pandemic responses. COVID-19 infections topped 44 million worldwide this week with nearly 1.2 million deaths. There have been 8.8 million cases and 226,000 deaths in the US.

Fauci discussed developments around COVID-19, unexpected elements, vaccine progress and access and treatments, in conversation with Linda-Gail Bekker – professor of medicine at the University of Cape Town, internationally respected infectious diseases researcher, COO of the Desmond Tutu Health Foundation (DTHF) and former president of the International Aids Society.

He said countries such as South Africa, with a united and centrally planned approach, had achieved reasonably orderly and effective responses to SARS-CoV-2, while the different reactions of America’s 50 states “just didn’t work”. Greatly impressive had been the “extraordinary bravery” of health care providers worldwide.

The webinar, titled “The Pandemic – North, South and forward”, was held on 26 October 2020 – the week in which In South Africa hoped to launch ENSEMBLE COVID-19 vaccine trials. The webinar was hosted by MedicalBrief and the DTHF, and sponsored by PPS.

Click here to watch the PPS webinar with Dr Anthony Fauci and Professor Linda-Gail Bekker: “The Pandemic – North, South and forward”

 

Epidemic surprises

Media have described Fauci, a young-looking 79 year old, as one of America’s most trusted medical figures. He is the scientific face of the pandemic globally and a lead member of the White House Coronavirus Task Force. Director of the National Institute of Allergy and Infectious Diseases since 1984, he has served six US presidents, and through four decades has been prominent in efforts to tackle viruses such as HIV-AIDS, SARS, MERS and Ebola.

Bekker described Fauci as “not only a very important scientific authority, but a very good friend of South Africa”. She asked what he had found most surprising about the epidemic – specifically this virus compared to others he has dealt with before.

A couple of points have been prevalent, Fauci said. “The first is the incredible efficiency with which this virus can spread from person to person. We often talk about our worst nightmare being a virus that jumps species, has a high degree of transmissibility via the respiratory route, and has the potential for a high degree of morbidity and mortality. It’s the worst case scenario, and unfortunately that’s what we’re seeing with this virus.”

A second aspect was notable and puzzling and made it very difficult to ‘message’ COVID-19. After “chasing viruses for 36 years”, Fauci has seen many things, he told Bekker: “You and I have both been knee deep in HIV-AIDS.

“This is so different because of the spectrum of disease, from 40% of people who have no symptoms to those who have symptoms, 80% of whom have mild symptoms. Then you have 15% to 20% to 25% who have severe or critical involvement, leading to the high degree of morbidity and mortality.

“When you have such a wide spectrum, some people – particularly young people – feel ‘Oh, this isn’t going to bother me. Most people of my age do very well. They recover and they’re fine’. In the meanwhile, the virus has killed over a million people worldwide and 226,000 people in the United States. You try to get across a message that this is something really serious, it’s historic in its seriousness, but there are still people who don’t take it seriously.”

“Hence the great disparity in the US about following simple, fundamental public health guidelines like wearing a mask, physical distance, avoiding crowds,” Fauci explained. That was why last week the US had the highest number of daily cases since the beginning of the pandemic – 83,000 in one day. “That is terrible. I’ve never seen anything like that.”

This second aspect raised parallels with HIV. Bekker agreed that there is a messaging problem. With HIV-Aids, the public messaging had to move from abstinence to safer sex. “Maybe we need to think about safer socialisation rather than this message that we can somehow prevent infection completely?”

“You hit the nail right on the head,” responded Fauci. “I have been preaching that we’ve got to get away from the mentality of either shutting down completely or the hell with it, do anything you want to do without any precautions.

“It is the same as back in the day with HIV, when we would say no to drugs or no sex at all. It doesn’t work that way. We don’t want to shut down the country and destroy the economy. But on the other hand, we don’t want people to say there’s no such a thing as public health measures.” Ways need to be found to operate more safely as opposed to shutting down.

North and South

Bekker said that South Africa, with 717,000 coronavirus cases and 19,000 deaths, leads the continent in terms of COVID-19 infection but is happily no longer in the top five countries worldwide. There clearly appeared to be differences in the severity of infection between the North and the South. Why had doom and gloom about Africa being hit, not come to pass?

There was “probably a complexity of reasons”, Fauci suggested. The US is very large and heterogeneous geographically, demographically – in many different ways. America’s 50 states have a degree of independence from central government.

“When you have a pandemic that is involving the entire country, you can’t have disparate responses where one state decides they want to do it one way, the other state the other way. Everybody’s got to pull together.”

Some other countries, including South Africa, were able to respond to COVID-19 more centrally, and it had been possible to gradually open up the economy and society from full lockdown through phases, in a fairly orderly fashion.

“The 50 different states did it 50 different ways and it just didn’t work. That’s the reason why we had a resurgence,” said Fauci. “We’re not pulling together as a unified country, whereas others – including South Africa – do it much more that way. That’s what the difference is.”

Was it not time for the US to mandate mask-wearing? The previous Friday, during a CNN interview, Fauci said exactly that: “If we can’t accomplish voluntarily the uniform wearing of masks, then we have to seriously consider mandating it,” he told the webinar.

Vaccines

South Africa is trialling three candidate vaccines as part of global trials, and is keen to know the latest on the vaccine front.

Fauci said the US was helping to subsidise, develop and facilitate the testing of six candidate vaccines. Two of them – the Moderna and Pfizer messenger RNA vaccines – started phase three of trials on 27 July and the AstraZeneca candidate is not far behind.

“We should be collecting data right now,” he explained. “We’re going to be there soon. The projection is that we will likely know by the middle of November whether or not we have a safe and effective vaccine, at least in those two candidates, with the others not far behind.”

Phase one data looked hopeful, with no significant safety signals. “Given that, we’ve already started producing, in large amounts, enough doses to start administering by the end of December, the beginning of January. I think we’re right on schedule.”

This was good news, said Bekker. One question was what vaccine efficacy was deemed worthy of deployment? Second, for public health benefit there was the question of coverage.

Said Fauci: “The trial is powered and designed to pick up 60% efficacy. I am hoping that we get to 70%, 75%. I’d love to get like measles with 98%, but I don’t think we will – if we do, wonderful, I’ll take it, but I think that’s unlikely.”

Regarding public health benefit and coverage, uptake is significant problem in the US, particularly among the most vulnerable communities. The most vulnerable, besides the elderly and people with underlying conditions, are African American and Latinxs, who comprise more than 30% of the population and have been hard-hit by COVID-19.

Among these minority groups, and particularly African Americans, 25% to 50% say they either definitely do not want as vaccine or they are not sure. “It would be terrible if we have a safe and effective vaccine and yet the most vulnerable are not using it,” Fauci said.

“So we’re doing what we did with HIV in the old treatment networks.” Community representatives are working to convince people that it is important to participate in clinical trials and take vaccines. “It’s not going to be easy. There’s a lot of scepticism.”

Plan B

Is there a plan to deal with not achieving reasonable efficacy with first generation vaccines, which are currently all focusing on the spike protein? Bekker asked.

There is, said Fauci. While the focus is on the advanced vaccine trials, there are multiple other and different candidates already being developed and trialled in early phase one. “We’re not going to stop. We’re going to try and get the best possible combination.

“And since this is a truly global pandemic, we’re going to have to have enough vaccine for billions and billions of people, not just millions of people. The more the merrier. And the more companies we can get in there, the better off we will be.”

Fauci said that ultimately, there would be head-to-head comparisons of the efficacy of the various vaccines, as there had been for other infectious diseases. “It’s going to require a lot of enrolments, but that’s OK.”

The question of access

Bekker liked Fauci comments, reported in media, that money is being risked but not safety. “It’s an important message to get out to everyone as we expedite and accelerate development of vaccines,” she said. Low- and middle-income countries are worried about access. “We had a bad experience with antiretrovirals.”

Fauci played a key role in the American PEPFAR initiative – the President’s Emergency Plan for AIDS Relief – which made sure the developing world had access to lifesaving HIV-AIDS treatments. What about life-saving COVID-19 vaccines?

The same approach as PEPFAR was needed, Fauci said. President George W Bush’s message to him was that there was a moral obligation to ensure that life-saving interventions are universally and uniformly available, and not only to countries that can afford it.

“As a global community, we need to make sure that we don’t have just rich countries getting [vaccines]. That’s the reason why when we contract with companies, we talk about billions of doses, not hundreds of millions of doses. To me it’s a moral obligation.”

So how might vaccine deployment play out? The US Advisory Committee on Immunisation Practices sets prioritisation. This year, the National Academy of Medicine also weighed in.

The recommendation is that health care providers on the frontline seeing COVID-19 patients should be first to receive a vaccine. “Followed by people with underlying conditions clearly associated with a poor COVID-19 outcome, followed by the elderly, followed by people with critical positions in the community – safety, keeping trains running, keeping electricity going – and then everybody else, all the healthy people,” Fauci told the webinar.

If there is the kind of vaccine success Fauci is hoping for, by the second or third quarter of 2021 vaccines will have been distributed. “The same thing should go globally also.”

Plan C

If there is not a good vaccine available by mid-2021 it would be necessary “to carefully double down on public health measures so that we don’t completely destroy the economy of the world”, said Fauci.

At the same time, effort and investment would need to be poured into therapies not only for advanced patients – such as remdesivir and dexamethasone – but also early treatment to keep people out of hospital, such as monoclonal antibodies or targeted antiviral drugs.

“We’re doing it anyway. But if it turns out that’s the only tool we have, we’re going to have to ratchet up, because if we can’t prevent infections completely by public health measures, at least we can mitigate against hospitalisation and death.”

There could be prophylactic options, said Bekker. South Africa is testing non-specific vaccines such as the MMR – measles, mumps and rubella – and BCG against TB. What are Fauci’s thoughts on shaking up the innate immune system to see if it can do some good?

“We haven’t led with that because we have some degree – I hope it’s not unfounded – of confidence that we will do well with standard adaptive immunity vaccines as opposed to innate immunity vaccines.”

He mentioned a Russian finding that after giving out an oral polio vaccine, there was a diminution in influenza because of innate immunity. “I think that will be something we have to seriously consider if we’re not successful with the classic vaccinations.

Vitamin D and monoclonal antibodies

Bekker said there had been scientific interest in Vitamin D as useful against viruses, but not many randomised controlled trials to explore its potential.

“I have a deep down, non-scientifically based prejudice for Vitamin D. I’m not ashamed to admit I take a few thousand units a day myself,” said Fauci. There had been strong studies in India and Africa looking at tuberculosis morbidity and mortality, showing a clear and positive relationship to either exposure to sun or high Vitamin D levels.

“To me, it’s such a benign thing that we should be pursuing it. We haven’t done the randomised placebo controlled trial because there are too many other things drowning it. But it’s something that we should take seriously.”

Bekker asked about the prospects of producing monoclonal antibodies in large volumes. This was possible with resources, said Fauci. Companies could make monoclonal antibodies at doses that could be prophylaxis.

On a personal note

The past year has been a ‘coronacoaster’ ride for Fauci and his family. There have been lows of unwarranted criticism and public aggression, and highs including scientific awards and a Tony Fauci bobblehead, T-shirts and masks. What, asked Bekker, has been most memorable?

There is one aspect that is series and one that is a little lighter, said Fauci. First, “the extraordinary bravery of the health care providers to throw themselves into this, in a way that endangers themselves literally every single day. And we’ve seen that globally.”

“On the lighter side is the extraordinary, surrealistic world that I’m in, where people are looking for something that represents truth, integrity and clarity. They picked me out because I’m visible. But it isn’t really me,” he said.

“We all want truth. We all want science. We all want clarity.” Fauci is impressed by how the world is galvanised around this. “You have misinformation and you have deception on one hand, and then on the other hand you have what we’ve lived our lives for – namely truth and science, data, evidence. Those are the things that will prevail.”

 

Click here to watch the PPS webinar with Dr Anthony Fauci and Professor Linda-Gail Bekker: “The Pandemic – North, South and forward”.

 

About webinar sponsor PPS

PPS Health Professions Indemnity was developed in response to the challenges South African health professionals face, from the aggressive litigation landscape to rising professional indemnity costs. This indemnity protection is delivered through the financial strength and security of the PPS Group. The focus is on sustainability, providing quality protection for the duration of your career as a health professional. More information on the solution is available in the Product Brochure.

 


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