Johnson and Johnson Vaccine has Arrived 

By  Dr. Mike Hansen

The NEW COVID Vaccine from Johnson and Johnson has arrived. It has 2 BIG advantages compared to the mRNA vaccines. One, it’s a single dose. Two, it does not require super-cold temperatures. This will make it way easier to mass vaccinate.

The study was called the ENSEMBLE Trial, a randomized, double-blind, placebo-controlled phase 3 study, meaning that thousands of patients are enrolled and assess the vaccine’s safety and efficacy.

Unlike the Pfizer / BioNTech and Moderna vaccines, mRNA vaccines, the Johnson and Johnson vaccine is a recombinant vector. In this case, it takes another virus, an adenovirus, to modify that virus to cause infection in the body. However, that virus can still serve as a delivery messenger to deliver the genetic code for some SARS-CoV-2 viruses. Specifically, the genetic code that codes for the spike protein of the virus.

Johnson and Johnson Vaccine

One of the huge advantages of this Johnson and Johnson vaccine is that it is a single-dose vaccine. The other big advantage of this Johnson and Johnson vaccine is that it can remain stable for two years at -20°C (-4°F), at least three months of which can be at temperatures of 2-8°C (36°F–46°F).

Why is this significant?
Because that means, unlike the mRNA vaccines, regular refrigeration will suffice for mass distribution.

But how effective is this Johnson and Johnson vaccine?
The ENSEMBLE trial enrolled over 43,000 participants ages 18 years and older from the United States, Latin America, and South Africa. About 1% of patients enrolled in the study developed covid. It was 66% effective at preventing moderate and severe Covid by day 28 after vaccination among all participants, including those who lived in regions with the new emerging viral variant such as the P1 variant in Brazil and B.1.351 variant in South Africa. Protection against SARS-CoV-2 was greatest in the United States at 72% and worst in South Africa at 57%.

About 95% of those in the trial who developed covid in South Africa were found to have been infected with the B.1.351 variant. That B.1.351 variant has been found to have some resistance to antibodies generated due to previous infections and other vaccines. Within the B.1.351 variant, the E484K mutation has “appeared sporadically” in multiple samples for months. Still, until recently, it didn’t appear to offer the virus an advantage in populations with no preexisting immunity.

But it’s a different story in places like South Africa, where many people had been previously infected. In South Africa, there has been a very high reinfection rate to the point where the previous infection does not seem to protect you.

But how protective is the Johnson and Johnson vaccine against SEVERE disease?
It was 85% effective in all regions by day 28, and there was no severe covid after day 49.

Does this mean the Johnson and Johnson vaccine is 100% effective at preventing severe covid by day 49?
We will only know for sure with time and once the full data from the study becomes available. It’s also worth noting that no one who received the Johnson and Johnson vaccine was hospitalized with covid or died with 28 days of getting this covid vaccine.
Preventing severe disease in a high percentage of people will significantly alleviate this virus’s devastation.

How safe is the Johnson and Johnson vaccine?
Serious adverse events, meaning side effects, were rare, with more participants in the placebo group reported adverse events than the vaccine group. This implies that some of the adverse events reported by patients in the placebo arm may have contracting actual COVID 19 disease. The overall rates of fever were 9%. The percentage of people who developed high fevers, meaning Grade 3 fevers, defined as greater than 39°C or 102.1°F) 0.2%.

So, Johnson and Johnson vaccine will soon be filing for Emergency Use Authorization in the United States. This comes in the nick of time because we have to vaccinate as quickly as possible before the new variants become the dominant strain. Because if that happens, the consequences could entail ineffective antibody protection, which means we would take a giant step backward to get this pandemic under control.

So far, about 450,000 Americans have died as a result of COVID. Even if the entire population started doing everything right – wearing masks, distancing…we are still likely to see over 100,000 deaths over the next 3 months. So realistically, we are much more likely to see way more than 100,000 people die over the next 3 months. So it’s a race not just to save lives. It’s a race to get as many shots in arms as possible. And it’s even more so a race to do this before the new variants become the dominant strain.

Doctor Mike Hansen, MD
Internal Medicine | Pulmonary Disease | Critical Care Medicine

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