The Food and Drug Administration is expected to issue an emergency use authorization (EUA) for Johnson & Johnson’s covid-19 vaccine soon, possible this weekend. This decision would make the third such vaccine available to Americans. So, it’s as good a time as any to go through the similarities and differences between the J&J vaccine and the two already out of Moderna and Pfizer / BioNTech.
The most important similarity between all three is their high effectiveness in preventing the life-threatening disease of covid-19. In an FDA analysis of clinical trial data from approximately 40,000 volunteers freed On Wednesday, the J&J vaccine proved to be 77% effective in preventing severe to severe diseases 14 days after vaccination and 85% effective in preventing severe to critical diseases 28 days later. It has generally been found to be 66% effective in preventing moderate to severe disease for 14 days or more.
The top line numbers are not as impressive as what we have seen from clinical trials of mRNA vaccines developed by Moderna and Pfizer / BioNTech, both of which are over 90% effective in preventing any symptoms. But the most crucial goal of any vaccine should be to keep people alive and free from the serious complications of the target disease – a goal that J & J’s version seems to achieve very well. In clinical trials, they did not existrelated hospitalizations or deaths observed in vaccinated persons after 28 days. None of these vaccines are likely to be 100% effective in prevention hospitalizations or deaths, but all will greatly reduce the chances of this happening.
The J&J vaccine has its own clear advantages. Namely, it is only a single shot, unlike the two-month program of more than one month recommended for either the mRNA vaccine. There are ongoing research tests on whether a second blow, made two months later, could increase its effectiveness. But for now, it’s the one-shot version that people will get access to first, assuming it’s FDA-approved. It is also more stable and durable at warmer temperatures, which means it can be stored in a typical refrigerator for longer and without immediate concern for damage once removed. (That being said, Moderna and even the Pfizer vaccine don’t seem to need ultra-cold storage as originally thought.)
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If you are worried about the novelty of mRNA technology behind other vaccines (which, to be clear, is actually three decades old), the J&J vaccine can make you feel more comfortable because of its familiarity. It works using a castrated adenovirus (meaning it can’t do more than normal) to carry the DNA of the coronavirus protein, the key the virus uses to invade cells. The mannequin virus enters a cell and causes the body to organize a specific immune response to the spike protein – one that should train it against reality.
The use of viral vectors as a delivery system in medicine is older than the mRNA method and comes with a longer safety experience. Although, like mRNA vaccines, it would be the first widely used adenovirus vaccine. Adenovirus vaccines have them potential limitations, such as pre-existing immunity to the virus used, which could weaken the vaccine’s effectiveness. In the case of the J&J vaccine, a type of adenovirus is used that infects people less often, which is meant to solve these limitations. And because it has been tested in different parts of the world with similar success, this should ease the concern that its effectiveness will vary wildly from country to country.
The J&J vaccine can easily win when it comes to potential side effects. The most common adverse events related to the vaccine were pain at the injection site (48.6%), headache (38.9%), fatigue (38.2%) and myalgia (33.2%). In contrast, more than 84% of people who received the Pfizer / BioNTech vaccine experienced pain around the injection site after the first or second blow, and 60% experienced fatigue. Potentially severe adverse events were rare for the J&J vaccine and there was no difference in frequency between those receiving the vaccine or placebo after the potential symptoms of covid-19 (0.4% in each group) were counted, which which should further indicate its safety.
As with other vaccines, people under the age of 60 were more likely to have symptoms, which is probably due to a stronger immune response. There was a possible, but still rare, risk of an allergic reaction to the vaccine, but only five patients in the study who received the vaccine had reactions shortly after the shooting and none had a severe reaction known as anaphylaxis. (One patient in the placebo group had a reaction.)
In its analysis, the FDA stated that more data should be collected before it is clear whether the allergic reaction is a real risk of the vaccine. But otherwise, he endorsed the vaccine as safe and effective, saying their analysis “supported a favorable safety profile, with no specific safety issues identified that would prevent the issuance of a EUA.”
Another consideration is that the J&J vaccine has been tested in the United States, South America and South Africa, at a time when important new variants of coronavirus have begun to appear. The data suggest that the vaccine should continue to provide good protection, if slightly diminished, against the variant first found in South Africa, probably the most worrying variant of all. And it can also provide some protection against asymptomatic infections, which is a great sign that it will reduce transmission.
On Thursday, the FDA Advisory Committee on Vaccines and Related Biological Products will meet to discuss study data and offer their recommendation for an emergency or non-emergency use authorization. And if things go as expected, the FDA will authorize it soon. Once authorized, J&J has SAPS they will be ready to deliver almost 4 million doses immediately. By the end of March, it is said to have 20 million doses available – a timeline similar to the early distribution planned by Moderna / Pfizer. Until then, all three companies had pledged to make a total of 240 million doses available to the public. Today, there are an average of 1.4 million Americans a day vaccine.
In short, the road to mass vaccination is likely to become less bumpy over time, especially if other candidates enter the picture at the end of this year, as expected. And you shouldn’t worry too much about what specific vaccine to get when you’re finally eligible, because it will all protect you from the worst thing covid-19 can do (although the J&V vaccine J may be most convenient for some) Most importantly, all will help end this pandemic as soon as possible.