The fight between science and anti-science continues, as evidenced by vaccine news.
The Food and Drug Administration (FDA) has quietly told vaccine makers to stick with the science. It wants them to comply with a set of guidelines that go beyond what the agency has said publicly.
The only public guideline has been that vaccines are, at least, 50% effective.
The guidelines make sense.
They are asking drug companies to hit a set of standards that go beyond what is normally requested. This includes waiting until participants in phase III trials have gone through at least two months of monitoring after receiving their last shot.
Other guidelines include having at least five of the infections result in severe illness in the placebo group for each trial. That would prove that the vaccine protects against the most devastating developments of the disease.
The trials should also have cases of Covid-19 in older people. These people are more vulnerable and have immune systems that can be less responsive to a vaccine.
However, the risk is that these are not yet hard-and-fast rules.
Tom Inglesby, director of the Johns Hopkins Center for Health Security, likes the new guidelines. Here is what he said about the vaccine news:
“The companies were only halfway through enrolling people at the end of August. They need time for more people to enter the trial, they need three to four weeks to get the second dose of vaccine, and they need at least two months of study after that. Vaccine trials take time. They just do.”
The pharmaceutical industry also likes having guidelines. The industry is distraught that confidence is slipping in taking the vaccine. The drop in confidence is due to the fact that the government is pushing every pharma firm to rush pell-mell into this.
We’ll have to see if science or anti-science wins this round.
The Big News
The Covid-19 pandemic will destroy at least 100 million jobs worldwide this year. That is according to the UN Conference on Trade and Development. It said if governments move toward fiscal tightening too early, the recovery could fizzle out.
Africa’s Covid Success
There were fears that Covid-19 would devastate much of Africa. But Africa has outperformed the dire predictions. It generated some of the world’s Covid-19 success stories. This is particularly true in West Africa. Countries there already had pandemic protocols in place after Ebola outbreaks. Some of the success stories include Liberia, Senegal and Rwanda.
J&J’s Covid Vaccine News
Thanks to positive results in earlier studies, Johnson & Johnson is in the final stage of clinical trials for its vaccine. Although they are a couple of months behind other Phase III trials in the U.S., the JNJ trials will be the largest. The trial will enroll 60,000 participants. The JNJ vaccine has big advantages over some of its competitors. JNJ’s vaccine does not need to be stored in subzero temperatures, and it may require just one dose instead of two.
Another Covid Reinfection Case
A healthy young health-care provider at a Virginia hospital was first infected by a patient in March. He recovered within 10 days. But 51 days later, he was reinfected by a household member. Genetic studies showed the first and second infections to be from slightly different strains of the virus.
The Coronavirus Also Attacks Bone Marrow
Even bone marrow may not be safe from the ravages of COVID-19. A study found previously unrecognized changes in newly produced immune cells, called monocytes, released into the blood from bone marrow. In COVID-19 patients with severe disease, the monocytes do not function properly. Treatments that prevent their release from the bone marrow may help reduce the exaggerated immune response that contributes to poor outcomes in patients with severe COVID-19.
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The Coronavirus Numbers
Deaths in the U.S. have climbed to over 200,000. This trails only three other mass casualty events in American history:
- 1918 H1N1 Pandemic – 675,000 deaths
- Civil War – 618,200 deaths
- World War II – 418,500 deaths
Here are the numbers on Wednesday at 8 a.m. ET from Johns Hopkins University:
- 31,643,198 Infected Worldwide
- 971,679 Deaths
- 6,897,541 Infected in the U.S.
- 200,818 Deaths in the U.S.
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Federal Reserve Chairman Jerome Powell is clearly worried.
He told Congress on Tuesday that the U.S. economy had so far proved “resilient” to the effects of the coronavirus.
But he said that might not last.
Powell did mention better data on housing and the labor market, as well as consumer spending. But he also warned that economic activity remained “well below” pre-pandemic levels. He also said:
“. . . the path ahead continues to be highly uncertain. A full recovery is likely to come only when people are confident that it is safe to re-engage in a broad range of activities. The path forward will depend on keeping the virus under control, and on policy actions taken at all levels of government.”
Considering his remarks, it is easy to understand the Fed’s actions last week . . .
It signaled it expected to keep interest rates near zero until at least the end of 2023.
This should keep a floor under the stock market . . . particularly tech stocks and the IPO market.
Yours in Health & Wealth,