Donald Trump wants a coronavirus vaccine widely available by the end of the year, even though his public health experts say it will take at least a year to 18 months, an ambitious schedule given that the mumps vaccine — considered the fastest ever approved — took four years to develop and adequately test for safety before approval for use.
“Damn the science! Screw safety, I just told people to drink bleach or huff Lysol for cripes sake! I want it now!”
What could possibly go wrong?
The New York Times reports, Trump Seeks Push to Speed Vaccine, Despite Safety Concerns:
President Trump is pressing his health officials to pursue a crash development program for a coronavirus vaccine that could be widely distributed by the beginning of next year, despite widespread skepticism that such an effort could succeed and considerable concern about the implications for safety.
The White House has made no public announcement of the new effort, called Operation Warp Speed, and some officials are apparently trying to talk the president down, telling him that it would be more harmful to set an unreasonably short deadline that might result in a faulty vaccine than to wait for one that is proved safe and effective.
But after the existence of the effort was first reported on Wednesday by Bloomberg News, the Department of Health and Human Services confirmed it. “Operation Warp Speed is clearly another extension of President Trump’s bold leadership and unwillingness to accept ‘business as usual’ approaches to addressing the Covid-19 crisis,” said Michael Caputo, the department’s assistant secretary for public affairs.
Mr. Trump’s order came after he grew frustrated by warnings from Dr. Anthony S. Fauci, the director of the National Institute of Allergy and Infectious Diseases, and other experts on the coronavirus task force, that development of a vaccine would take a year to 18 months, and that even that schedule might be ambitious. He told Alex M. Azar II, the health and human services secretary, to come up with a faster program.
According to one official, the idea would be to indemnify the major pharmaceutical and biotechnology companies from liability if the vaccines cause sickness or death, and to involve the Pentagon in the testing program. But most of the military’s efforts have focused on defenses against biological weapons, not viruses that arise naturally or are transmitted by community spread.
Seventy to 100 companies, groups and academic institutions around the world are working on vaccines, including Oxford University and several projects in China. But many of the most experienced vaccine makers and experts are in the United States.
Note: The Times reported earlier, In Race for a Coronavirus Vaccine, an Oxford Group Leaps Ahead:
In the worldwide race for a vaccine to stop the coronavirus, the laboratory sprinting fastest is at Oxford University. Scientists at the university’s Jenner Institute had a head start on a vaccine, having proved in previous trials that similar inoculations — including one last year against an earlier coronavirus — were harmless to humans.
That has enabled them to leap ahead and schedule tests of their new coronavirus vaccine involving more than 6,000 people by the end of next month, hoping to show not only that it is safe, but also that it works.
The Oxford scientists now say that with an emergency approval from regulators, the first few million doses of their vaccine could be available by September — at least several months ahead of any of the other announced efforts — if it proves to be effective.
Scientists at the National Institutes of Health’s Rocky Mountain Laboratory in Montana last month inoculated six rhesus macaque monkeys with single doses of the Oxford vaccine. The animals were then exposed to heavy quantities of the virus that is causing the pandemic — exposure that had consistently sickened other monkeys in the lab. But more than 28 days later all six were healthy, said Vincent Munster, the researcher who conducted the test.
“The rhesus macaque is pretty much the closest thing we have to humans,” Dr. Munster said, noting that scientists were still analyzing the result. He said he expected to share it with other scientists next week and then submit it to a peer-reviewed journal.
A cautionary note: Immunity in monkeys is no guarantee that a vaccine will provide the same degree of protection for humans.
Mr. Trump, in the middle of a re-election campaign, may be satisfied with declarations that a vaccine is coming soon. And even before any vaccine receives formal approval, it could be designated for “emergency use,” meaning that it could be given to health professionals.
That’s right, frontline medical workers will be the new rhesus macaque monkeys for drug testing in Trump world. Medical professionals know better, they will not comply.
When companies say that it will take at least a year to 18 months to develop a vaccine, they are sometimes counting from January — when China provided the genetic code of the virus — and sometimes from when the firms began to work toward a solution.
But the timing is not completely within their control. Much depends on the success of the trials and review by the Food and Drug Administration. Most other countries have a similar process.
In more normal times, a vaccine can take upward of a decade to get through all the regulatory approvals. Some officials note the dangers of rushing: During the Ford administration, a rushed vaccine for swine flu caused several dozen deaths and damaging side effects.
Yes, let’s take a side trip down memory lane. The Smithsonian recounts The Long Shadow of the 1976 Swine Flu Vaccine ‘Fiasco’:
In the spring of 1976, it looked like that year’s flu was the real thing. Spoiler alert: it wasn’t, and rushed response led to a medical debacle that hasn’t gone away.
“Some of the American public’s hesitance to embrace vaccines — the flu vaccine in particular — can be attributed to the long-lasting effects of a failed 1976 campaign to mass-vaccinate the public against a strain of the swine flu virus,” writes Rebecca Kreston for Discover. “This government-led campaign was widely viewed as a debacle and put an irreparable dent in future public health initiative, as well as negatively influenced the public’s perception of both the flu and the flu shot in this country.”
[T]his is a story about one time over 40 years ago when poor decision-making on the part of the government led to the unnecessary vaccination of about 45 million citizens.
On February 4 1976, a young soldier named David Lewis died of a new form of flu. In the middle of the month, F. David Matthews, the U.S. secretary of health, education and welfare, announced that an epidemic of the flu that killed Pvt. Lewis was due in the fall. “The indication is that we will see a return of the 1918 flu virus that is the most virulent form of flu,” he said, reports Patrick di Justo for Salon.
Spanish influenza [1918 flu] was another form of swine flu, di Justo writes, and researchers at the Centers for Disease Control thought that what was happening could well be a new, even deadlier strain that was genetically close to the 1918 strain.
To avoid an epidemic, the CDC believed, at least 80 percent of the United States population would need to be vaccinated. When they asked Congress for the money to do it, politicians jumped on the potential good press of saving their constituents from the plague, di Justo writes.
The World Health Organization adopted more of a wait-and-see attitude to the virus, writes Kreston. They eventually found that the strain of flu that year was not a repeat or escalation of the 1918 flu, but “the U.S. government was unstoppable,” di Justo writes. They had promised a vaccine, so there needed to be a vaccine.
This all happened in the spring, with emergency legislation for the “National Swine Flu Immunization Program,” being signed into effect in mid-April. By the time immunizations began on Oct. 1, though, the proposed epidemic had failed to emerge (although Legionnaires’ Disease had, confusing matters further.)
“With President Ford’s reelection campaign looming on the horizon, the campaign increasingly appeared politically motivated,” Kreston writes. In the end, one journalist at The New York Times went so far as to call the whole thing a “fiasco.” Epidemiology takes time, politics is often about looking like you’re doing something and logistics between branches of government are extremely complicated. These factors all contributed to the pandemic that never was.
The real victims of this pandemic were likely the 450-odd people who came down with Guillain-Barre syndrome, a rare neurological disorder, after getting the 1976 flu shot. On its website, Reflections on the 1976 Swine Flu Vaccination Program, the CDC notes that people who got the vaccination did have an increased risk of “approximately one additional case of GBS for every 100,000 people who got the swine flu vaccine.”
So let’s review: A Republican president, in an election year, who promised Americans a vaccine for an epidemic, and rushed it into production before it was adequately safety tested, politically motivated for a president to claim credit during an election year — and it resulted in unnecessary injury to Americans. (Some historians say it contributed To Ford’s loss to Jimmy Carter).
Sound familiar? Only the stakes are much higher this time because the COVID-19 coronavirus pandemic is the real deal, killing tens of thousands already, and it is only just getting started.
“History doesn’t repeat itself, but it often rhymes” – often misattributed to Mark Twain.