The FDA is prepared to give vaccine makers lots of leeway on Covid-19 booster shots. Meanwhile, colleges and universities have emerged as among the the worst virus hotspots.
The FDA told vaccine makers they should start studies on tweaked vaccines “sooner rather than later.” The urgency is due to the rapid spread of more contagious variants.
Importantly, the FDA said pharmaceutical companies could do trials with just a few hundred people. These trials could only take two or three months. It says there is no need for the large phase 3 trials that were required for the original emergency use authorizations (EUA).
If the vaccine is made by the same manufacturer, in the same way, the FDA will allow them to amend their EUAs. This avoids getting a new approval.
The FDA’s guidance requires studies that show whether antibodies produced by a vaccine can tackle a new strain. Manufacturers will also be required to prove their vaccines are not significantly less effective than the previous ones were for the original variant.
Moderna, AstraZeneca and Novavax are already preparing for clinical trials of vaccines and boosters tailored to the new variants.
Other vaccine makers including BioNTech/Pfizer have said they could adapt their shots. Pfizer just announced plans for new studies on Feb. 25.
The FDA is also in talks with regulators around the world. The hope is for coordinated vaccine switches at roughly the same time.
The Big News
Virus Hotspots: College Campuses
Colleges and universities are virus hotspots. Coronavirus cases have continued to emerge by the tens of thousands this year at colleges. More than 120,000 cases have been linked to U.S. colleges and universities since Jan. 1. And more than 530,000 cases have been reported since the beginning of the pandemic. At least 17 colleges have already reported more than 1,000 cases in 2021.
The Solution to Protecting Against the Variants?
Could the solution to protecting against the variants of the coronavirus be more of the current vaccines? Moderna and Pfizer have announced plans to test vaccines specifically targeted at variants of the virus. But they also plan to test the idea of simply giving people three doses instead of two of their vaccines. Scientists believe it is at least conceivable it could work.
Vaccine Manufacturing Bottleneck
The number of available Covid-19 vaccine doses is steadily rising. However, a shortage of physical space that meets standards for pharmaceutical manufacturing is a major bottleneck to further expansion. This is according to drug makers, industry construction experts and officials involved in the U.S. vaccine program.
‘Long Covid’ Is Serious Problem
Thousands of Covid-19 patients continue to suffer serious and and lingering symptoms many months after their initial of infection. A WHO report on “long Covid” said about one in 10 Covid-19 patients are still ill 12 weeks after their infection. And many suffer symptoms for far longer.
GSK Drug Aids Elderly Covid Patients
GlaxoSmithKline will extend a trial testing an experimental rheumatoid arthritis drug on elderly patients suffering from pneumonia related to Covid-19. The trial will now focus solely on the elderly as it seeks to firm up encouraging findings so far. A trial started in May has shown that the drug known as otilimab helps patients over 70 with severe Covid-19 get off mechanical ventilation or high-flow oxygen support faster.
The Coronavirus Numbers
Here are the numbers from Friday at 8 a.m. ET from Johns Hopkins University:
- 113,086,223 Infected Worldwide
- 222,267,690 Vaccines Given Globally
- 2,509,565 Deaths
- 28,413,635 Infected in the U.S.
- 68,274,117 U.S. Vaccine Doses Administered
- 508,314 Deaths in the U.S.
Engineer Quits Tesla and SpaceX – Launches New EV Stock
One of the TOP engineers behind Tesla Motors and SpaceX just QUIT. And he’s now creating a brand new EV battery. Go here to grab Pre-IPO shares of this new EV stock.
Stock markets were in retreat yesterday as bond yields soared. The 10-year Treasury yield moved above 1.6% for the first time since the pandemic began. The “fear” is still that an economic recovery from the pandemic will fire up inflation.
This prompted investors to ditch stocks, especially richly valued growth names. The tech-heavy Nasdaq fell 3.5%. The broader S&P 500 was down 2.5%. Tesla declined another 8%, while Apple and Amazon tracked about 3% lower.
The sharp rise in Treasury yields reminds me of the 2013 “taper tantrum.” Back then, a jump in yields followed comments from then-Fed chair Ben Bernanke that he would taper off the central bank’s emergency bond-buying program.
That tantrum faded quickly. I suspect this one will as well.
Meanwhile, Wall Street plans to invest $475 million in this new EV battery stock. Go here for urgent details.
Yours in Health & Wealth,