The Trump administration embarked on one of the most ambitious vaccine development efforts in history. Operation Warp Speed is likely to produce a Covid-19 inoculation in a fraction of the years it would normally take. By doing so, it could save the lives of hundreds of thousands of people and economies around the world.
But the administration has also offered timelines for a vaccine that run counter to almost every experience in pharmaceutical history. On Tuesday night, President Donald Trump said an injection could be ready in three to four weeks. Then on Wednesday, Paul Mango, deputy director of policy staff for the Department of Health and Human Services and one of the top leaders of the Warp Speed program, said that all Americans could get vaccinated by the end of March.
Mango said there are enough doses in production and that the trials are progressing at a rate that “combining those two will allow us to vaccinate all Americans before the end of the first quarter of 2021.” A few hours later, White House press secretary Kayleigh McEnany said that “we believe it will be widely available by the end of” this year, although he also referred to the doses of the vaccine that are being produced by then, rather than the that are actually distributed.
Mango and McEnany’s statements were contradicted by the director of the Centers for Disease Prevention, Director Robert Redfield, who told Congress on Wednesday that it would probably take most Americans until late spring or summer of next year. in having access to a vaccine. . Other senior US health officials have said that a vaccine is not likely to be ready until the end of the year and that expanding access to the more than 300 million people living in the US will take longer.
“It would be an aspiration to do that,” said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. “But I think it’s more towards the middle or end of the year that people can be vaccinated. It depends on what the vaccine is.”
The United States has launched many ships. Pfizer Inc., Moderna Inc. and AstraZeneca Plc have advanced rapidly. Early data looks promising, and late-stage trials in tens of thousands of volunteers could produce a rapid response.
But to roll out a vaccine widely early next year, it’s worth considering what has to go right:
• One of the vaccines has to work.
• The vaccine that works has to be one of the few that are already in late-stage trials.
• There cannot be a major security issue or delay.
• Clinical trials must generate strong evidence.
• The FDA has to accept that evidence and review it quickly.
• Manufacturing has to go almost to perfection.
• Hundreds of millions of doses must be administered nationwide, probably with some degree of low temperature storage requirements.
Even in the vaccination efforts that the United States undertakes every year, the goal of wide acceptance is difficult to meet. For the 2017-2018 flu season, only 37% of Americans were vaccinated, according to the CDC. Many people get it at work, school, pharmacies, or hospitals – places that are mostly closed or many Americans are avoiding due to the pandemic.
There are some loosely understood rules for running a pharmaceutical company, in addition to the need to generate a reasonable return for shareholders.
A first rule is not to kill anyone. The second is to help people live better and longer lives. The third is not to be sued by securities regulators.
It’s a simple set of goals that are often met with the brutal reality of drug development, often summed up by experts in the field with the often repeated pearl, “science is hard.” Every year the pharmaceutical industry spends billions on failures. Drugs seem like miracles, then it turns out to be a mirage Much of the money that companies invest in research goes to projects that stop because they do not help people or could harm them.
The result is that most companies (there are, of course, exceptions) are conservative in their pronouncements. And some have been preparing for a vaccine. Merck & Co. has quietly bet that the first shot down the line won’t necessarily be the best, and that its experimental vaccine could outperform the first winners. Some form of vaccine will likely be needed for years as well, leaving plenty of room for gradual improvements such as better protection, longer-lasting immunity, and safer safety.
To that end, earlier this month, the National Academies of Sciences, Engineering, and Medicine released a report summarizing experts’ recommendations for distributing a Covid-19 vaccine.
On page 11, a key lesson from previous mass vaccination efforts is cited: “Underpromises and Overdelivers.”
Having violated the first half of that advice, the best hope now is for the United States to comply with the second.
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