Mounting promises on Covid-19 vaccines are fueling false expectations – STAT

Vaccines to prevent Covid-19 infection are hurtling through development at speeds never before seen. But mounting promises that some vaccine may be available for emergency use as early as the autumn are fueling expectations that are simply unrealistic, experts warn.

Even if the stages of vaccine development could be compressed and supplies could be rapidly manufactured and deployed, it could take many more months or longer before most Americans would be able to roll up their sleeves. And in many countries around the world, the wait could be far longer still perpetuating the worldwide risk the new coronavirus poses for several years to come.

That reality is being obscured by reports that some of the earliest vaccine candidates including one from the biotechnology company Moderna and another from University of Oxford may within months have enough evidence behind them to be administered on an emergency use basis.

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Michael Osterholm, director of the University of Minnesotas Center for Infectious Diseases Research and Policy, is worried people arent preparing for the possibility of a fall wave of infections which some experts fear will be bigger than what weve seen so far because they expect a vaccine will be at hand.

Ive actually heard higher education experts say, Well, you know, were kind of counting on the vaccine maybe by September because we keep hearing about that. And of course, in their mind, theyre equating [that to mean] colleges and universities will have the vaccine, he told STAT.

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Osterholm and other experts make clear that there will not be enough vaccine for college-age students in that time frame, even in the best-case scenario. Its likely any supplies that will be available if any of the vaccines prove themselves to be protective by the fall will be designated for health care workers and others on the front line of the response effort.

I dont think were communicating very well at all with the public, because I keep having to tell these people, you know, even if we had a vaccine that showed some evidence of protection by September, we are so far from having a vaccine in peoples arms, Osterholm said.

Assuming a vaccine can be developed quickly, the issue of manufacturing is not a small one. Production of some vaccine candidates could be more easily ramped up than others, noted Emilio Emini, who is leading work at the Bill and Melinda Gates Foundation on the issue.

Should some of the more scalable vaccines prove to be protective, its conceivable that they could be made at existing plants, rather than require the construction of whole new facilities. Production of this type of candidate could reach hundreds of millions of doses within about a year, Emini said. But any vaccines that would require bricks-and-mortar construction is obviously going to take longer to reach those output levels.

The World Health Organization, which is closely monitoring the field of candidate Covid-19 vaccines, lists more than100 projects, though many are being designed in academic laboratories without commercial production capacity. Of the total, eight are already being tested in people, four of them in China.

Among the others is an RNA vaccine project being developed by Pfizer and partner BioNTech, which began testing four possible vaccines in a compressed Phase 1/2 trial in the U.S. on Tuesday. The companies estimate they will be able to produce millions of doses this year, in facilities in the United States and Europe; by 2021, production could reach hundreds of millions of doses though final figures will depend on how much vaccine it takes to protect each person, said Philip Dormitzer, Pfizers vice president and chief scientific officer.

Weve set a goal that were pursuing. And the data are going to tell us to what degree thats an easy goal or very difficult goal to meet but its not going to be very easy, Dormitzer said.

The WHO has called for equitable sharing of Covid-19 vaccines, insisting they should be seen as a global resource. But there have been concerns from the earliest days of this pandemic that countries that are home to vaccine production facilities will nationalize any output to ensure domestic needs are met before vaccine can be exported for use elsewhere.

Robin Robinson, who led the Biomedical Advanced Research and Development Authority from 2008 to 2016, said the agency has spent billions of dollars building up vaccine production capacity in the United States based on that assumption.

A recent recipient of BARDA funding is Moderna, which is expanding production capacity at its Norwood, Mass., facility. Were going to be making millions of doses per month in 2020, ramped to tens of millions of doses a month in 2021, CEO Stphane Bancel said recently.

We are highly aware that given almost everybody on the planet needs to be vaccinated, were going to need a lot of capacity. And we are discussing with a lot of parties how to get there, Bancel said. Are we going to get to a place where we can do seven billion doses next year? The answer is clearly no. But are we in a place where we could be even doing another five-times, ten-times increase from the tens of millions of doses per month? Were working very hard and when we have a clear plan well communicate about it.

The Cambridge, Mass.-based company announced last week that it had signed a deal with Swiss pharmaceutical company Lonzo to help produce 1 billion doses of the vaccine in the U.S. and in Switzerland.

While China has extensive vaccine production capacity and several developing countries including India, Indonesia, and Brazil are among the worlds largest vaccine producers and exporters, a sizable amount of the manufacturing capacity belonging to pharmaceutical companies that sell vaccine in North America and Europe is based in the United States.

Marie-Paule Kieny, who formerly led the WHO group responsible for spurring development of epidemic and pandemic vaccines and drugs, said when the global health agency worked on pandemic planning in the lead-up to the 2009 H1N1 influenza pandemic, it was proposed that health care workers around the world have first access to vaccine. That group, she said, is estimated to be about 2% of the global population roughly 156 million people.

I think its reasonable to say that this should be the first target, because as weve seen everywhere, including in the U.S., when you have a health system which cannot accommodate sick people, then everybody suffers, said Kieny, who is now research director at Inserm, the French equivalent of the National Institutes of Health.

Health care workers would likely followed by people at the highest risk those 65 and older and people with chronic health conditions, like diabetes, that have been seen to increase the risk of dying from Covid-19, Robinson said.

I dont think that the general population will have vaccine probably until the second half of 2021. And thats if everything works OK, he said.

The Advisory Committee on Immunization Practices, an expert panel that makes recommendations to the Centers for Disease Control and Prevention on vaccine use, is typically tasked with drawing up the priority groups during pandemics.

Regardless of who gets vaccines when, its believed that most if not all of the new vaccines will require at least two doses to be effective, so any estimates of numbers of doses available in the autumn will need to be divided by two to find out how many people could expect to be vaccinated.

Osterholm said the public both here and abroad need clearer communications about realistic time lines to Covid-19 vaccine access. When vaccines do start to become available, demand will be enormous and supply will be minimal.

Its going to be like filling Lake Superior with a garden hose at first, he warned. Lets just be honest, whichever country gets the vaccine first is going to both be in the drivers seat and a very difficult spot.

Eight billion people are going to want this vaccine overnight when it becomes available.

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Mounting promises on Covid-19 vaccines are fueling false expectations - STAT