The World Health Organization buys a hundred million doses of Chinese vaccines that aren’t all that effective against COVID-19; asking what’s holding up the FDA from giving full final approval to the Pfizer, Moderna, and Johnson & Johnson vaccines; sorting out whether people who had COVID-19 before should get vaccinated; and two left-of-center journalists inadvertently diagnose major flaws in how politics is covered.
For those who thought the U.S. rejoining the World Health Organization would lead to better decision-making in that international organization . . . nope. The WHO’s COVAX vaccine-distribution program decided to buy “millions of doses” of two of China’s COVID-19 vaccines, Sinopharm and Sinovax. Chinese state-run media puts the figure at 110 million doses.
You remember Sinopharm, right? That’s the Chinese-made vaccine which trials found prevents hospitalization 79 percent of the time! Oh, just note that “the trial was not designed and powered to demonstrate efficacy against severe disease in persons with comorbidities, in pregnancy, or in persons aged 60 years and above.” So, we’re not sure how effective the vaccine is against people who are old or who have comorbidities, which are admittedly two of the groups most vulnerable to COVID-19. Look at the bright side, Sinopharm keeps four out of five young healthy people out of the hospital!
And then there’s Sinovac, which is like Sinopharm, just, well, not as effective. That’s the vaccine which Brazil’s Butantan Institute found had an efficacy of 51 percent against symptomatic SARS-CoV-2 infection, and it is slightly less effective against two of the variants.
Sinovac™: A bigger gambling thrill than the gaming tables of Macau!
But look at this ringing endorsement from Gao Fu, the director of China’s Centers for Disease Control and Prevention, from back in April: “The efficacy of [the] existing vaccines is not high. . . . The levels of antibodies generated by our vaccines are lower than mRNA vaccines and the efficacy data are also lower. I think it is a natural conclusion that our inactivated vaccines and adenovirus vectored vaccines are less effective than mRNA vaccines.” A day later, he insisted he never said what he just said.
Finally, late last week, CNBC reported that, “weekly COVID-19 cases, adjusted for population, have remained elevated in at least six of the world’s most inoculated countries — and five of those nations rely on vaccines from China.”
If this stuff were any less effective, it would be coming out of a Pez dispenser.
Good call, World Health Organization, good call. Money well spent!
What’s Holding Up the FDA from Giving Non-Emergency Approval to the Vaccines?
The anti-vaxxers and vaccine skeptics didn’t like this Corner post — surprise — but fine, let’s take up the issue of whether and when the FDA will move its approval of the Pfizer, Moderna, and Johnson & Johnson vaccines from their current emergency-use authorization to full, lasting approval, what’s formally called a BLA — biologics license application.All Our Opinion in Your Inbox
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More and more medical professionals have urged the FDA to formally take that final step. Dr. Eric J. Topol, a professor of molecular medicine at Scripps Research who has served on multiple FDA advisory committees, wrote in the New York Times op-ed page that the “vaccines have overwhelmingly been proved safe and effective by clinical trials, independent research and the experience of millions of people around the world who received them . . .” and yet their FDA approval remains conditional.
One big consequence of the lack of a BLA is in the U.S. military. The Pentagon cannot require troops to get a vaccine that only has emergency-use authorization. As of the end of June, 77 percent of U.S. Navy personnel, 70 percent of U.S. Army personnel, 61 percent of U.S. Air Force personnel, and 58 percent U.S. Marine Corps personnel have received at least one dose of a COVID-19 vaccine.
Considering how this is the single-most scrutinized vaccine ever, and that more than 184 million Americans have at least one shot of one of them in their bloodstreams . . . the fact that the FDA hasn’t given those vaccines its final “Good Housekeeping seal of approval” does seem a little incongruous.
But there’s no particular delay or snag in the approval process of the COVID-19 vaccines; FDA approval usually takes years. Pfizer submitted a rolling application back in May. “Data to support the BLA will be submitted by the companies to the FDA on a rolling basis over the coming weeks, with a request for priority review.” Moderna did the same June 1, and Johnson & Johnson did the same June 5. Researchers from all the companies are monitoring patients and collecting data, up to six months after the second dose, and will also send the FDA relevant manufacturing and facility data.
Topol argued that federal regulators should be close to done with the review already. “The FDA has already reviewed some of the submissions and has provided feedback to the manufacturers. The emergency authorizations were granted more than six months ago. That’s more than ample time for the agency to conduct plant inspections and review the applications.”
Dr. Marty Makary, professor of surgery and health policy at the Johns Hopkins University School of Medicine, argued late last year that the FDA consistently moved at the sluggish pace of government bureaucracy, even when lives were hanging in the balance:
Meanwhile, the slower-moving FDA scheduled a meeting for Thursday to review the Pfizer data, almost three weeks after Pfizer submitted its application on November 22. Given that 1) there are no serious adverse events from the vaccine, 2) the dataset to analyze is small, and 3) the difference in infection rate between the placebo and vaccine groups is so significant, it’s only fair to ask, what has the FDA been doing for almost three weeks?
. . . I’ve conducted more than 100 clinical studies with my colleagues at Johns Hopkins and have reviewed thousands of statistical outputs from my own research and research that I have reviewed externally. I’ve also served on data safety monitoring boards. There is simply no scientific reason why the review that the FDA is tasked to do could not be done in a few days without cutting any corners on safety. Staring for 3 weeks at the data from the Pfizer vaccine trial does not add any more information than reviewing it in 2 days. The FDA should not compromise on the integrity of its review, just move faster . . .
But would full FDA approval really be a game-changer and persuade the skeptics? The FDA has already declared to Americans, loudly and clearly, that the vaccines are safe to put into their bodies. The agency has declared that the vaccines protect people from COVID-19, that they dramatically reduce the likelihood of spreading the virus to others, and that the vaccines’ side effects are minimal and temporary. Nor has the agency hand-waved away all concerns about risks. It issued a warning about the risk of thrombosis-thrombocytopenia syndrome in the Johnson & Johnson vaccine, declaring that “the available data suggest that the chance of TTS occurring is very low, but the FDA and CDC will remain vigilant in continuing to investigate this risk.” Just this week, the FDA also issued a warning about the “very low” risk of Guillain Barré syndrome among those who received the Johnson & Johnson vaccine. The FDA “identified 100 suspected cases” out of 12.8 million Johnson & Johnson shots administered.
Are the people who haven’t gotten the vaccine yet really holding back because the vaccines have only an emergency-use authorization? Or are they just looking for any old excuse to doubt the safety of the vaccines and will simply move on to other objections when the FDA approves one or more biologics license applications? The problem with the vaccine-skeptic interpretation of this is that it implies that the FDA knows there’s something wrong with the vaccines . . . and yet they’ve allowed 334 million shots to go into Americans’ arms so far.
As for the question of whether those who have already had COVID-19 should get vaccinated, right now, the CDC doesn’t mince words: “Yes, you should be vaccinated regardless of whether you already had COVID-19. That’s because experts do not yet know how long you are protected from getting sick again after recovering from COVID-19.” It is worth noting that a new study from the Cleveland Clinic found that those previously infected with COVID-19 were at extraordinarily low risk for reinfection: “[Among] 52,238 employees in an American healthcare system. COVID-19 did not occur in anyone over the five months of the study among 2,579 individuals previously infected with COVID-19, including 1,359 who did not take the vaccine.” That said, we know reinfection is possible, and a new study suggests that past infection may not be all that protective against the Delta variant: “Antibodies from 56 people who were infected with SARS-CoV-2 in the past did not neutralize Delta very well, but after one dose of either the AstraZeneca, Pfizer/BioNTech, or Moderna vaccines, antibodies from all 56 neutralized all four strains.”
One of the best parts of the U.S. vaccination effort is the progress among seniors, as 79 percent of all Americans over age 65 are fully vaccinated, and 88.7 percent have at least one dose. That leaves about 11.5 million American seniors left unvaccinated.
The largely vaccinated U.S. is almost done with this pandemic, but not quite all the way there. The increase in infections over the past few weeks isn’t that much of a worry; vaccination prevents severe illness, hospitalization, and death, not infection entirely. But 129 Americans died of COVID-19 yesterday, and the evidence suggests that almost all of those deaths were preventable.
Read the Source post on Independent Newspaper Nigeria.