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Progress on the Vaccine Front

Research associate Phuong-Danh Tran, of RNA medicines company Arcturus Therapeutics, researches for a coronavirus vaccine at a laboratory in San Diego, Calif., March 17, 2020. (Bing Guan/Reuters)

On the menu today: why we shouldn’t be too discouraged by the news that AstraZeneca is pausing stage-three testing of its otherwise promising candidate for a SARS-CoV-2 vaccine, why Joe Biden had to clean up Kamala Harris’s mess, and an observation about how the quarantine helped set the stage for looting in America’s cities.

The Encouraging Signs on the Vaccine Front

If you’re a large company, working with Oxford University on arguably one of the strongest contenders for a vaccine against SARS-CoV-2, and one person in your stage-three trial develops an unexplained illness . . . you slow the test process down and try to figure out what’s going on. That illness could be a side effect of the vaccine, or it could be coincidental. This test participant might have some previously undiagnosed condition that could be interacting with the vaccine, or some sort of genetic factor could be at work. Stage three of the vaccine test involves 30,000 adult volunteers; if only one person is having a potential adverse effect, that’s a good sign.

The delay is disappointing and frustrating, but it’s also the right choice for human health and the creation of a vaccine that will work as intended for everyone.

A spokesperson for AstraZeneca, a frontrunner in the race for a Covid-19 vaccine, said in a statement that the company’s “standard review process triggered a pause to vaccination to allow review of safety data.”

In a follow-up statement, AstraZeneca said it initiated the study hold. The nature of the adverse reaction and when it happened were not immediately known, though the participant is expected to recover, according to an individual familiar with the matter.

The spokesperson described the pause as “a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials.” The spokesperson also said that the company is “working to expedite the review of the single event to minimize any potential impact on the trial timeline.”

An individual familiar with the development said researchers had been told the hold was placed on the trial out of “an abundance of caution.” A second individual familiar with the matter, who also spoke on condition of anonymity, said the finding is having an impact on other AstraZeneca vaccine trials underway — as well as on the clinical trials being conducted by other vaccine manufacturers.

There are a handful of other vaccine programs that are in stage three, meaning large-scale testing. One is a partnership between Moderna Therapeutics and the U.S. National Institutes of Health, one is a partnership between BioNTech, Fosun Pharma, and Pfizer, and one is being run by the Murdoch Children’s Research Institute in Australia. Four others are in development in China — one at CanSino Biologics, one at Sinovac Biotech, one at Sinopharm, and one at the Wuhan Institute of Biological Products, which should not be confused with the Wuhan Institute of Virology. (Hey, if anybody would have head start in figuring out a virus like this, it would be a lab in Wuhan, right?)

Gilead Sciences, Roivant Sciences, and Regeneron Pharmaceuticals have SARS-CoV-2 treatments in stage three as well.

And then there are the Russians, who announced they had developed and approved a vaccine last month. Could the Russians . . . actually have a good vaccine? It sounds like this vaccine could work and looks promising, but the Russian government is declaring victory at halftime.

On Aug 11, 2020, Russia became the first country in the world to approve a vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The vaccine, which is based on two adenovirus vectors, was developed by the Gamaleya National Center of Epidemiology and Microbiology (Moscow, Russia). Its approval was announced by President Vladimir Putin. “I know [the vaccine] works quite effectively, helps to develop strong immunity, and has gone through all the necessary tests”, declared Putin at a cabinet meeting. Nonetheless, there are widespread concerns that the approval is premature. At the time of approval, the vaccine had not even started phase 3 trials, nor had any results on the earlier stage trials been published.

Since then, the phase 1/2 results have been published in The Lancet. The vaccine induced a strong immune response in all 76 participants. Presumably these results were available to the Russian Ministry of Health. For regulators such as the US Food and Drug Administration (FDA) and the European Medicines Agency, however, data on immune response alone would not generally be an adequate basis for approving a vaccine. “Immune response might not be directly proportional to the degree of protection—you can only find this out in large-scale trials”, explains Peter Openshaw, professor of experimental medicine at Imperial College London (London, UK).

The Russian vaccine is named Sputnik V, after the Soviet-era space program.

[Insert joke about how Sputnik never returned to Earth here.]

Is the vaccine being rushed? That all depends upon what you mean by “rushed.” Doctors and medical researchers want an effective and safe vaccine in the bloodstreams of the general public as quickly as possible — that’s how we get back to “normal.” Vaccines usually take seven to ten years to develop, and the vaccine for the mumps previously held the record for fastest development (four years).

SARS-CoV-2 wasn’t even declared an international concern until the end of January, so yes, this is the fastest vaccine development in human history . . . because it had to be. The rapid development shouldn’t stun us; the world has never had so many well-educated medical minds tackling the same problem at once on so many fronts with so many advanced technological innovations.

Yesterday, the CEOs of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer, and Sanofi announced “a united commitment to uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines.” They understand this vaccine won’t work if people won’t take it, and people won’t take it if they don’t trust the process that developed it.

Will Americans Trust the Vaccine When It Arrives?

Our fight against the virus was not helped when Kamala Harris contended that an unsafe or ineffective vaccine might be rushed to the American public for political purposes — and that counterevidence about the vaccine’s safety or effectiveness could be “muzzled, suppressed, sidelined”:

DANA BASH: As you know, President Trump has promised a coronavirus vaccine by the end of the year or maybe sooner. Would you trust that vaccine?

HARRIS: I think that we have learned since this pandemic started, but really before that, that there’s very little that we can trust that can comes out of Donald Trump’s mouth. From the beginning of this pandemic, he has called it a hoax. He has muzzled the public health experts. He has minimized the seriousness of it. He has created false expectations for the American people and American families, even though, if he had listened to the scientists and the experts, he would have understood the gravity of it and the power that he, as president of the United States, has to actually save lives. And none of those were his priorities. His priority was to do whatever he thought was politically expedient. And so, no, I would not trust his word. I would trust the word of public health experts and scientists, but not Donald Trump.

BASH: But do you trust that, in the situation where we’re in now, that the public health experts and the scientists will get the last word on the efficacy of a vaccine?

HARRIS: If past is prologue, that they will not, that will be muzzled, they will be suppressed, they will be sidelined, because he’s looking at an election coming up in less than 60 days, and he’s grasping for whatever he can get to pretend that he has been a leader on this issue, when he has not.

BASH: So, let’s just say there is a vaccine that is approved and even distributed before the election. Would you get it?

HARRIS: Well, I think that’s going to be an issue for all of us. I will say that I would not trust Donald Trump. And it would have to be a credible source of information that talks about the efficacy and the reliability of whatever he’s talking about. I will not take his word for it. He wants us to inject bleach. I — no, I will not take his word. [Emphasis added.]

First, this is a nonsensical scenario, as the president isn’t just going to be able to hide test results showing the vaccine doesn’t work or has bad side effects. He’s not going to roll out a Trump-branded vaccine that is only available at his hotels, resorts, and golf clubs, over the objections of Dr. Fauci, Dr. Birx, and the rest.

Second, if you want to ensure that Americans don’t trust a vaccine, and that vaccination proceeds along partisan lines, statements such as Harris’s are how you do it. The last CBS News poll showed just 21 percent of Americans would get a vaccine “as soon as possible.” The question might be moot, as presumably not everyone will be able to get it all at once, and authorities are likely to want to vaccinate the most vulnerable first.

One of my regular readers asked why the CDC or other government agencies aren’t starting a public-awareness campaign, encouraging people to take the vaccine when it’s available. First, it will take some time before 320-some million doses are available, so health authorities will presumably want to prioritize some people — health-care workers, the elderly, the immunocompromised — before moving on to lower-risk demographics. Low demand among the general public might be helpful, at least at first.

Third, it’s likely that some people would interpret a “get your vaccine when it’s ready” public-awareness campaign as a “the vaccine is ready” announcement and show up at their local CVS or Walgreens asking for the coronavirus vaccine, adding to public confusion, anger, and distrust.

Joe Biden was left to clean up Harris’s remarks. “I’m worried if we did have a really good vaccine people would be reluctant to take it. So, he is undermining public confidence,” Biden said of the president. “But pray God we have it. If I could get a vaccine tomorrow, I’d do it. If it cost me the election, I would do it. We need a vaccine and we need it now. We have to listen to the scientists.”

I hope Biden’s line, “If it cost me the election, I would do it,” permeates the public consciousness. That’s how important this is. We need the public to have faith in genuine expertise and reliable data. I’m not so certain that a vaccine will be ready by November 3, but if it is, Biden ought to take it. He turns 78 shortly after the election, he’s survived two brain aneurysms and had his gallbladder removed, he’s on blood thinners, and win or lose, his life requires him to interact with a lot of people. He would probably survive infection with the coronavirus, but I can understand his staff and loved ones not wanting to roll the dice on that.

Taking a vaccine that works is the right thing to do in a pandemic, even if there’s a chance your political opponent might get credit for the good news.

Did the Quarantine Set the Stage for the Looting?

A sharp observation from Michael Brendan Dougherty: “By adopting quarantines, the cities empty, and the protective presence of citizens is withdrawn from shopping and nightlife districts, thus inviting much of the chaos and looting we saw this summer.”

ADDENDUM: Kevin Williamson, as succinct as ever: “To abolish the Electoral College would mean a substantial change in the American constitutional order, and such a thing requires broad consent — broad consent that does not exist and is unlikely to come into being any time soon. One cannot help but suspect that this issue would have less urgency if there were more Democrats in Wyoming.”


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