Today we take a deep dive into the vaccine approval process . . . and begin with the eye-opening revelation that a warehouse in Maryland is amassing “tens of millions of vaccine doses that, for now, are being stockpiled with no date set for distribution.”
The Warehouse of Already Manufactured COVID Vaccines, Waiting to Be Used
A little-noticed article in the Baltimore Sun on January 29 revealed that the United States has “tens of millions of doses” of vaccines manufactured, packed up, and ready to go . . . but they still need authorization and approval from the FDA:
Covered head to toe in sterile garments, workers inside a modern manufacturing plant in East Baltimore have been making coronavirus vaccine for months — tens of millions of doses that, for now, are being stockpiled with no date set for distribution.
None of the vaccines at the Emergent BioSolutions factory has yet been authorized for use. But among the pharmaceutical companies contracting with Emergent is Johnson & Johnson, which reported promising trial results Friday and is expected to submit data to federal regulators within a week for emergency authorization.
The Emergent BioSolutions factory was built with the help of federal government dollars before the pandemic for just such an assignment, making large batches of complex vaccines and therapies.
Emergent, based in Gaithersburg, is an experienced vaccine maker, producing its own products such as a smallpox vaccine kept in U.S. stockpiles. It has nine facilities globally, including another facility in South Baltimore near the city’s professional sports stadiums, where it fills vials of vaccines and therapies.
The company has received millions in federal dollars to boost production of COVID-19 therapies and vaccines, including at the East Baltimore factory near Johns Hopkins Bayview Medical Center.
Emergent is now producing four vaccines, two of which are just for human trials.
It is producing large quantities of the other two for possible distribution to the public: Johnson & Johnson’s and an AstraZeneca vaccine. There is no date set for AstraZeneca to seek authorization for its vaccine.
You may recall reading last year that part of the plan for Operation Warp Speed was to make a calculated gamble, manufacturing the vaccine candidates while they were and are being evaluated for effectiveness. This is part of that effort. If and (likely) when the FDA approves the Johnson & Johnson vaccine and the Oxford/AstraZeneca vaccine, the U.S. will have tens of millions of doses ready to distribute.
In a recent interview, Dr. Rick Nettles, the vice president of the pharmaceutical branch of Johnson & Johnson, said, “If we’re gra[n]ted emergency use authorization in late February within days we would start to ship the initial supply of that 100 million doses and hopefully people would be able to receive the vaccine shortly thereafter.”
Yesterday on The Today Show, Dr. Anthony Fauci suggested FDA approval could come even quicker:
The J&J data right now that we discussed last week is being reviewed with the FDA right now, so we could see literally within a week or so that they wind up getting the kind of emergency use authorization. I don’t want to get ahead of the FDA, but I would not be surprised if this happens within the next week or two.
Is the Oxford/AstraZeneca vaccine safe and effective? Probably. The United Kingdom approved its use December 30 and started using it already. By early January, India, Argentina, the Dominican Republic, El Salvador, Mexico, and Morocco authorized it as well; the European Union’s medical authorities signed off on it on January 29. Switzerland wants to see more data. Germany approved the vaccine, but only for those under age 65.
AstraZeneca is eagerly touting the results of a third-phase trial of more than 17,000 test subjects in the United Kingdom, Brazil, and South Africa that showed no severe cases and no hospitalizations, more than 22 days after the first dose:
Results demonstrated vaccine efficacy of 76 percent after a first dose, with protection maintained to the second dose. With an inter-dose interval of 12 weeks or more, vaccine efficacy increased to 82 percent. . . . The analysis also showed the potential for the vaccine to reduce asymptomatic transmission of the virus.
Some experts have criticized the fact that AstraZeneca combined the efficacy results from what’s essentially two different trials and say the company will need to conduct another trial properly evaluating the effectiveness of the half-dose full-dose regimen.
“Small mistakes are common, but giving thousands of participants the wrong dose unintentionally is not a common mistake. Time will tell whether this particular mistake leads to a discovery, but at this point in time there is a lot of uncertainty around the findings,” said Dr. Philip Smith, an assistant professor in the department of kinesiology and health at Miami University in Ohio.
Smith, whose research focuses on public health and health policy, believes AstraZeneca will seek approval for the full dose, which is 62 percent effective.
The big question is whether regulators will trust the 62 percent, considering the sample size was smaller than intended, said Smith.
(When discussing the reports of 20 million missing doses this week, and worries that “the crucial supply is boxed away in warehouses,” I used the image of the giant warehouse full of crates seen at the end of Raiders of the Lost Ark. But apparently there really is a giant government-funded warehouse full of vaccine doses!)
If more people knew that the U.S. has a stockpile of tens of millions of doses of vaccines sitting in warehouses, some of which are already being used in other countries sitting in warehouses, we would be having an extremely heated debate about whether the FDA is reviewing the data fast enough. (Apparently, the country is too focused on Marjorie Taylor Greene to have this discussion.)
Yesterday Matt Yglesias observed: “It’s amazing that not only is this vaccine not approved, there’s no political pressure to approve it. No members of Congress talking about this, no questions in the briefing room.”
You may recall that the notion of members of the executive branch or Congress pressuring the FDA to approve a vaccine candidate quickly was precisely the nightmare scenario we were told we had to avoid last fall. Back in October, New York governor Andrew Cuomo declared that Americans couldn’t trust the FDA and the CDC in their assessment of a coronavirus vaccine, and that he will only trust the assessments of his own state-level agencies. A month earlier, 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.”
Do we think health officials in the United Kingdom, India, the European Union, and all of those other countries are going to look at the study data on the Oxford/AstraZeneca vaccine and come to dramatically different conclusions than our FDA officials? Do we think public-health and drug-approval officials in those countries are particularly reckless or inattentive?
Or is this a moment for regulatory nationalism? Should Americans trust the assessment of foreign health officials when we have our own FDA assigned with the role of looking out for Americans’ health?
You may or may not find it clarifying that House speaker Nancy Pelosi does not trust the United Kingdom’s system for evaluating and approving vaccines. “We need to be very careful about what happens in the UK. We have very stringent rules in terms of the Food and Drug Administration here, about the number of clinical trials, the timing, the number of people and all the rest,” Pelosi said in October. “My concern is that the UK’s system for that kind of judgment is not on a par with ours in the United States. So if [prime minister] Boris Johnson decides he is going to approve a drug and this president embraces that, that is a concern that I have.”
But you don’t have to look too hard to find smart people with extensive backgrounds in medical research who think the FDA is moving far too slowly, at least in these particular circumstances. The more-contagious South African variant of SARS-CoV-2 is now spreading in our country.
Daniel Elton lays out a detailed argument here. One point that jumps out is that Pfizer sent its paperwork to the FDA on November 22 and the agency approved the vaccine on December 11. Moderna sent its paperwork to the FDA on November 30, but the FDA scheduled the review meeting for December 17. Does it really require three weeks to review the data during a pandemic where thousands of people are dying each day?
Over at The Dispatch, Dr. Marty Makary, a professor at the Johns Hopkins University School of Medicine, wrote in early December, “As a Johns Hopkins scientist who has conducted more than 100 clinical studies and reviewed thousands more from the scientific community at large, I can assure you that the agency’s review can be done within 24 to 48 hours without cutting any corners. They just need to work harder.”
The Biden administration could urge the FDA to speed up its evaluation of the J&J and Oxford/AstraZeneca vaccines . . . but that’s exactly what Biden, Harris, and other Democrats spent the fall demonizing.
ADDENDUM: A detail in Therese Shaheen’s piece on the NR homepage that should not be missed:
Much like financial reporting of dubious economic-growth statistics, China’s reported pandemic case counts deserve scrutiny. The Johns Hopkins COVID-19 tracker has the PRC, with a population of 1.4 billion, having experienced 100,000 cases, fewer than Bahrain, with 1/1,000th the population. At 4,800 deaths, the PRC — where the virus originated — reportedly has experienced fewer deaths than in the U.S. state of Connecticut (3.56 million population). Of course, the truth is impossible to know, so we simply report implausible Chinese official data. It has been well-documented by citizen-journalists and others that China seriously repressed reporting about the virus in November and December 2019, well before the world was aware of the problem. Doctors were censored in filing reports about a new and uncertain flu-like virus they were seeing in patients. It has now been established that the official statistics the country released well into 2020 were off by as much as 100 percent.
If the Communist government were confident in its current reporting, why has it strong-armed attempts by the World Health Organization and countries in that body to seek transparency about the origin and handling of the outbreak? Foreign journalists have limited access, and citizen-journalists continue to be harassed. In December 2020, Zhang Zahn drew a four-year prison sentence after a three-hour trial for her reporting about what was happening in Wuhan around the time of the outbreak, which was not the model of public health or virus eradication that the Communist government had presented to the rest of the world. Zhang was convicted for “picking quarrels and provoking trouble.” There obviously is ample indication that — despite the world’s apparent belief that “the China model” has dealt with the virus — the truth on the ground is quite different.