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USA TODAY panel: ‘ Best news so far’ on vaccines
Although the COVID- 19 outbreak is looking worse than ever, news from vaccine makers is fueling optimism – maybe even jubilation – among experts in the field.
Normally restrained and cautious, a panel of experts convened by USA TODAY could barely contain its enthusiasm over the latest effectiveness figures from both Moderna and Pfizer/ BioNTech, whose vaccine candidates have been shown to be about 95% effective, while not raising any serious safety concerns.
“It’s the best news so far this year,” said Florian Krammer, a virologist at the Icahn School of Medicine at Mount Sinai in New York City.
The proof of effectiveness and safety also marks a shift from the development to distribution phase of the vaccine process.
While both companies and others making vaccines depended on tens of thousands of Americans to volunteer for clinical trials, beginning as soon as next month, millions of Americans will get to choose whether to get vaccinated.
That will require sophisticated logistics: to get the vaccines delivered, get them in people’s arms, remind people to come back weeks later for a second shot, and record any problems.
It also will require scientists and others to convince hundreds of millions of Americans – starting with front- line health care workers – that the vaccine is a crucial tool in the fight against COVID- 19.
“Having a vaccine that no one uses would be a disaster,” said Peter Pitts, president and co- founder of the Center for Medicine in the Public Interest, a New York- based nonpartisan think tank.
Pitts and Krammer are members of the expert panel USA TODAY has relied on for six months to gauge progress of vaccine development. This month their estimate took its largest leap yet.
How the clock works
The members judge the time on a clock that began at midnight with the discovery of the virus in early 2020, and ends at noon, when a vaccine is freely available across the U. S.
In June, the panel’s first median time was 4 a. m. By last month, the sun had risen and it was 8 a. m. For November, the time shot ahead to 9: 30 a. m. – the biggest forward tick so far.
The candidate vaccines have been advancing at a breathtaking pace, said Dr. Paul Offit, director of the Vaccine Education Center and an attending physician in the Division of Infectious Diseases at Children’s Hospital of Philadelphia. If anyone had asked scientists in January, when the genome of the virus was first published, whether 11 months later two huge clinical trials showing such effectiveness and safety would have been completed, “no one would have said that was possible,” Offit said.
The irony is that developing the vaccines – with an estimated $ 11 billion government price tag – was considered the biggest task. Instead, the cheapest way to stem the tide of infections, wearing masks, socially distancing and avoiding crowds, turned out to be the real challenge.
“Vaccines were the hard part. Hygienic measures, which are arguably equally, if not more powerful – that we couldn’t do,” Offit said.
A first wave of front- line medical workers could start getting vaccinated this holiday season but getting a vaccine into the arms of most Americans is still a long way off, the panel said.
Authorization of one, possibly two, vaccines is expected within weeks.
“That means we can begin inoculating health care and other essential workers even before we’re done with the Thanksgiving leftovers,” said Pitts, who oversaw the Food and Drug Administration’s public outreach programs during the George W. Bush administration.
Health workers come first
On Wednesday, U. S. Health and Human Services Secretary Alex Azar said there will be 40 million doses of vaccine available by the end of December, enough to vaccinate about 20 million people. Front- line health care workers are expected to be at the first in line.
With two vaccines so far along, the focus is shifting from whether a vaccine is possible to how it will get out into the world, said Dr. Kelly Moore, associate director of immunization education at the Immunization Action Coalition.
“At that point, the gears driving our clock toward noon transition from vaccine research and testing to vaccine supply, vaccination program capacity, and demand,” she said.
New leadership, same challenges
At this point, the election of Joe Biden to the presidency won’t have much effect on vaccine development and authorization, panelists said. That speedy pace was set months ago by President Donald Trump.
“You really need to give the administration credit for doing this,” Offit said.
The change in administrations could affect Americans’ collective understanding of the pandemic and vaccines and their willingness to get immunized.
The first job for Biden will be convincing the 40% or so Americans hesitant about the vaccine that it’s their patriotic duty to line up for a jab, Pitts said.
Panelists also expect a Biden administration to provide clearer and more consistent messaging about the science and safety of the vaccines – and the need to wear masks and stay physically distanced.
“We are likely to see greater focus on masks and other ‘ low tech’ mechanisms for mitigating transmission,” said Duke University Law School professor and health law expert Arti Rai.
Biden has made clear he will trust science advisers and federal medical officials. That will help, said Pamela Bjorkman, a structural biologist at the California Institute of Technology.
“I think we can now look forward to the message that all decisions will be based on the science,” Bjorkman said.
‘ Remarkable’ speed
The apparent effectiveness of both vaccines is a game- changer, said Prakash Nagarkatti, an immunologist and vice president for research at the University of South Carolina.
Nagarkatti was especially happy to see data from the Moderna clinical trials that seemed to indicate its vaccine was effective in the elderly and minorities. Because those groups have been among the hardest hit by the pandemic, a strong, effective vaccine is “very encouraging,” he said.
It’s difficult to remember that only nine short months ago one big unanswered question was whether the spike protein – now so well- known that it has showed up in cartoons and as a Halloween costume – was indeed the place to focus efforts.
“These early results suggest that they picked a great target,” said Moore, chair of the World Health Organization Immunization Practices Advisory Committee. It also means the other vaccines targeting the spike protein may be similarly successful.
To have this all happen in the space of 11 months is amazing, said Dr. Michelle McMurry- Heath, president and CEO of Biotechnology Innovation Organization, an industry group.
“The data on the effectiveness of both Moderna’s and Pfizer/ BioNTech’s vaccines are extremely encouraging. The speed at which they and many other biopharma companies have mobilized to develop a vaccine is both remarkable and unprecedented,” she said.
The new vaccines may produce more antibodies against SARS- CoV- 2, the virus that causes COVID- 19, than are produced in people who are recovering from a case of COVID- 19.
“These mRNA vaccines are very unique in the history of vaccines and may lead to a more robust immune response if the body’s own machinery is being harnessed to produce a protein ( S or spike protein),” said Dr. Monica Gandhi, an infectious disease expert at the University of California, San Francisco.
Their very newness also raises potential concerns, Rai said. “Pfizer’s and now Moderna’s convincing results are a tremendous step forward. However, because a product using an mRNA platform has never been approved before, we do have uncertainty about largescale manufacturing and distribution.” Many questions still remain.
“Will the vaccine only keep you from getting sick, or will it also block asymptomatic infection and transmission? What will its longer- term safety record look like? Will the vaccine’s protection decline over time, and how long will it last? Despite the uncertainty, these strong early results give us confidence moving forward,” Moore said.
Even with a vaccine that works, hurdles remain. The most obvious is both the Pfizer and Moderna vaccines require two shots three or four weeks apart.
Getting all Americans full access to vaccine will take many months, in part because it’s not all yet made, in part because vaccinations take time to work, and in no small part because the logistics are daunting.
“I expect vaccines to be widely available to general public in the middle of next year, due to limited production capacities and tremendous challenges in distributing vaccines,” said Soo- Haeng Cho, a professor of operations management and strategy at the Tepper School of Business at Carnegie Mellon University.