Why do I keep seeing all of these red flags?
Courtesy of WaPo:
The first coronavirus vaccine that aims to protect people with a single shot has entered the final stages of testing in the United States in an international trial that will recruit up to 60,000 participants.
The experimental vaccine being developed by pharmaceutical giant Johnson & Johnson is the fourth vaccine to enter the large, Phase 3 trials in the United States that will determine whether they are effective and safe. Paul Stoffels, chief scientific officer of J&J, predicted that there may be enough data to have results by the end of the year and said the company plans to manufacture 1 billion doses next year.
Three other vaccine candidates have a head start, with U.S. trials that began earlier in the summer, but the vaccine being developed by Janssen Pharmaceutical Companies, a division of J&J, has several advantages that could make it logistically easier to administer and distribute if it is proved safe and effective.
The company is initially testing a single dose, whereas the other vaccines being tested in the United States require a return visit and second shot three to four weeks after the first one to trigger a protective immune response. The J&J vaccine can also be stored in liquid form at refrigerator temperatures for three months, whereas two of the front-runner candidates must be frozen or kept at ultracold temperatures for long-term storage.
“A single-shot vaccine, if it’s safe and effective, will have substantial logistic advantages for global pandemic control,” said Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston, who partnered with J&J to develop the vaccine.
I, of course, remain skeptical of any vaccine which might get released before the election.
And actually the FDA might make that impossible.
Also courtesy of WaPo:
The Food and Drug Administration is expected to spell out a tough new standard for an emergency authorization of a coronavirus vaccine as soon as this week that will make it exceedingly difficult for any vaccine to be cleared before Election Day.
The agency is issuing the guidance to boost transparency and public trust as it approaches the momentous decision of whether a prospective vaccine is safe and effective. Public health experts are increasingly worried that President Trump’s repeated predictions of a coronavirus vaccine by Nov. 3, coupled with the administration’s interference in federal science agencies, may prompt Americans to reject any vaccine as rushed and potentially tainted.
The stakes are high: polls show the relentless politicization of the race to develop a vaccine is taking its toll. Pew Research Center recently reported that the percentage of people who said they would get the vaccine if it were available today has dropped to just over 50 percent from 72 percent in May.
The guidance, which is far more rigorous than what was used for emergency clearance of hydroxychloroquine or convalescent plasma, is an effort to shore up confidence in an agency that made missteps during the pandemic. While it is being reviewed by the White House Office of Management and Budget, elements of it are already being shared with vaccine makers. Under it, the FDA would ask manufacturers seeking an emergency authorization — a far quicker process than a formal approval — to follow participants in late-stage clinical trials for a median of at least two months, starting after they receive a second vaccine shot, according to two people familiar with the situation who spoke on the condition of anonymity to discuss information before it is made public.
Well, that is good news.
However, even with these newer restrictions, I think I am going to wait it out for a few months past the initial release of the vaccine to see if it really works as advertised.
At this point, it does not seem prudent to rush into anything until I have a chance to really examine the data.