Conn. shines in COVID-19 vaccine gold rush
We’re witnessing a global gold rush, financed by you and me, as four dozen or so COVID-19 vaccines vie for approval in China, Russia, Europe and the big prize, the U.S. Food and Drug Administration.
The good news, if we can call it that now that we’ve reached 1 million deaths worldwide, is that Connecticut carries a hefty pick-axe in this quest, with key policy voices and groundbreaking science.
Pfizer, in Phase 3 clinical trials for a drug largely developed in Groton, says it will have results as soon as October. Paris-based Sanofi expects to launch its Phase 3 trials in December and have results in early 2021 with an entry made in Meriden, using the same concept as the revolutionary flu vaccine that same outfit launched a few years ago.
Both global companies sold 100 million doses to us, the taxpayers, at prices in the range of $2 billion, even before places such as Yale New Haven Health (a Pfizer test site) signed up its share of the tens of thousands of brave guinea pigs in this headlong medical cliff-dive.
The White House says we’ll have mass vaccinations delivered — not just approved, not just manufactured, but delivered — by April. And just for show, in time for the Nov. 3 election, the feds have demanded Connecticut and other states turn out a plan by mid-October detailing how we intend to distribute these life-saving injections.
Sure, the same administration that dismantled U.S. epidemic planning starting in 2017, and whiled away two precious months after the outbreak in China as the president lied to the American people, now wants to look like Eisenhower’s Allied Forces on D-Day.
It’s a compelling investment, for sure, totaling
$11.111 billion in announced deals so far dished out to companies that will make a fortune for their shareholders if they win. Gee, I thought we didn’t like socialism.
Maybe all of this will work. But I wouldn’t count on crowding into Yale Bowl for, say, Paul McCartney’s
78th birthday next June, fortified by mass vaccinations.
Four tough hurdles
A lot can go wrong with Operation Warp Speed, as they call it, starting with four bold facts: No. 1, vaccines typically take 10 years or even more from the time they’re developed until they’re approved, let alone manufactured and marketed. We’re shooting for less than a year — and the two prospects furthest along, from Pfizer and Bostonbased Moderna, both deploy a genetic technology that’s never gained approval in any vaccine.
No. 2, public trust in a potential vaccine, and in the Trump administration’s handling of science, is rightly battered because of the perception — or the reality — of political meddling.
No. 3, even some vaccines that win approval have failed in the scale-up and delivery. Consider, the Pfizer and Moderna drugs must be stored in deepfreeze — minus 112 degrees Fahrenheit in the case of Pfizer’s entry.
No. 4, we’re making a vaccine for a disease we still know little about. Can a person who’s had COVID-19 catch it again and reinfect others? Is it fundamentally a lung issue or a cardiovascular issue? How often would we need the vaccine?
I dunno, and no one else does either, though smart people like Dr. Tom Balcezak, chief medical officer of the Yale New Haven Health system, are working as fast as they can.
Balcezak told me it’s possible for the large-scale tests now underway to show meaningful results quickly if all goes perfectly. Most vaccine side-effects
happen soon after injection, and if the numbers reveal effective protection, we have a gold vein.
“The expert consensus is the FDA is under so much pressure and the companies are working so hard, my personal bet is that there will be an initial FDA approval ... by the first of the year and maybe sooner,” Balcezak said.
“You could have a vaccine approved say, Dec. 15,” he added, “But you may not be able to get the scale of 200 million shipped, administered ... before the middle of June.”
June is a more realistic target date for an approval for widespread vaccinations, said Dr. Scott Gottlieb, the Westport resident who was President Donald Trump’s FDA chief until April 2019, on CBS Face the Nation Sept. 20. “What you really want is a vaccine available for mass inoculation before you head into the fall of 2021,” he said.
Trials can only go so fast
OK, so we’re a year away under that optimistic scenario. Let’s not quibble over a few months, even though we’ve already seen a major trial by AstraZenica halted due to a feared reaction in a patient in Great Britain.
The real issue is whether this massive effort can yield results before the virus runs its course — and that’s not at all clear.
Certainly it’s possible to speed the approval by con
ducting different phases at the same time and by making sure the FDA studies every blip of data on the day it arrives. But there’s a limit to that. We’re talking about long-term population health.
These Phase 3 studies, by design, are 22 to 24 months, and often it takes more than one to prove the result — in this case, an FDAdetermined 50 percent effectiveness rate, which, by the way, ain’t spectacular.
“From the beginning I’ve told anybody that wants to talk to me about it, don’t believe the hype,” said a person directing one of the sites for a major clinical study of a COVID vaccine, not in Connecticut. The person is not authorized to speak about the trial and requested anonymity.
“Let’s say they find it’s safe and you tolerate it,” the person said. “We don’t even know what it’s doing for you ... the only way to test this is to follow people for this length of time.”
The time can compress if the sample size is large enough, Balcezak said, and that’s the hope here. One new trial, led by Johnson & Johnson, has 60,000 participants.
‘Unlikely to be needed’
Manon Cox is the former CEO of Protein Sciences in Meriden, the company now owned by Sanofi that’s working on a protein-based vaccination along with London-based GSK. Now advising vaccine devel
opers, the East Haven resident is skeptical not only of the supercharged timeline, but of the whole need to vaccinate a majority of humans.
As a top executive at Protein Sciences, starting in 1998, she spent 13 years just getting approval for a new type of flu vaccine, called Flublok — for a disease that’s very well understood. The company used its platform to work on emergency vaccines for the avian flu, then the previous SARS (coronavirus is a SARS), then Ebola and Zika, mostly without success, often because the pandemic threat would pass.
Coronavirus? We don’t really know how the biology works, Cox told me, echoing other experts. “How can we develop a proper vaccine? What is the exact response that we need to see in people in order to get somebody to be protected?”
One of the ironies, Cox and Balcezak both pointed out, is that if the incidence of COVID-19 wanes, it becomes harder to show that a vaccine works. In the United States on average, we’re seeing fewer than 1 percent of the population test positive for it over two months — and it’s far less than that in some places, for some groups. Couple that with the “noise” from the upcoming flu season, and one quick study could easily fail.
And while vaccines work
by stimulating a response in the body to fight the disease, the COVID virus may defy that. “You’re going to develop a vaccine that induces neutralizing antibodies. But we also know that the people who got really sick and died, they also developed neutralizing antibodies,” Cox said — in contrast to the way the flu works.
In Cox’s view, it may ultimately make sense to vaccinate old and sick people, although she agrees the crisis is urgent.
“The virus will be with us for a long time, but we will become more tolerant to the virus and in the end, a vaccine is unlikely to be needed,” she said, at least for everyone. “Don’t think that anybody would be doing these ridiculously high-cost studies if the government wasn’t paying for it.”
‘ The FDA is on trial’
We’re seeing a lively debate about whether the Trump administration would issue a so-called Emergency Use Authorization prematurely. Gottlieb, the former FDA chief, coauthored a Sept. 20 opinion piece in the Wall Street Journal titled, “You Can Trust the FDA’s Vaccine Process,” describing a culture of career professionals who can’t be intimidated.
That was followed by a rebuke on Thursday in Fortune by two of Yale’s big names, Dr. Albert Ko of the School of Public Health and
Jeffrey Sonnenfeld of the School of Management — both advisers to Gov. Ned Lamont, Ko as co-chairman of the coronavirus reopening committee. They spelled out the decline in public trust and the evidence of meddling by Trump and his appointees, including Alex Azar, secretary of Health and Human Services, which includes the FDA and the agency that funds vaccine development.
Two big ones: Two weeks ago, Azar barred the FDA from issuing new rules — a power grab Gottlieb criticized on Face the Nation — and last week, when the FDA moved to require outside opinions before granting emergency vaccine approval, Trump threatened to overrule it.
“Given the Trump administration’s pressure to have a vaccine approved before Election Day, the FDA is on trial along with the vaccines themselves,” Ko and Sonnenfeld concluded.
Just the fact that we’re having this discussion should alarm every one of us. Ko and Sonnenfeld to say the least are not cloistered academics locked in the Harkness Tower.
Ko, according to the Washington Post, had dinner in New Haven on Feb.
27 with his Med school pal and boating buddy, Peter Marks, the FDA career scientist who heads up drug approvals. Marks, a Star Trek fan, pitched and named Operation Warp Speed in April but, perhaps ominously, left the effort to return to the regulatory side — where he’s the key decider.
And Sonnenfeld last week convened more than
100 CEOs of top companies and organizations in one of his regular summits. Overwhelming majorities in his instant poll “said that the U.S. response is worse than other industrialized nations and that the government response had increased the number of deaths in the U.S.,” Yale reported.
That death toll, now climbing past 205,000 at a rate of 750 per day, is reason enough why Operation Warp Speed might make sense despite the hurdles. But no one should have faith in a vaccine that’s approved by political leaders and no one should think this rush for vaccine gold is the whole answer.
“I still believe that what we need today is a treatment,” said Cox, the former Protein Sciences CEO, “not a vaccine.”