28/02/2021
🆘 J&J vaccine trial data released 🆘
Yesterday J&J released their ENSEMBLE trial data in preparation for their meeting with the FDA (Food and Drug Administration) in the US for emergency use approval. And it looks goooooooood!
It looks as if the vaccine provides strong protection against severe disease and death from COVID, and it may reduce the spread of SARS-COV2 by people that are vaccinated!
Here is a small summary of the findings so you can all be in the loop.
📍There were 43783 participants in this trial data, 21895 received the vaccine, and 21888 received the placebo.
📍The vaccine had an overall efficacy of 72% in the US and 64% in South Africa, even with our new strain. This is 7% higher efficacy in SA than was initially reported in earlier data.
📍The vaccine showed an 86% overall efficacy in the US against severe COVID and 82% in South Africa, meaning a vaccinated person has a significantly lower risk of being hospitalised or die.
📍0 people (yes, none!) in the vaccine group needed ventilation or ICU admission, compared to 5 in the placebo group. 0 people in the vaccine group died of COVID, compared to 7 in the placebo group. This is so significant. Read the number of people vaccinated in the first point of this post!
📍The data shows this vaccine is safe with much fewer mild side-effects than the Pfizer and Moderna vaccines. The most reported side-effects were pain at the injection site, fatigue, muscle pains, nausea, and headache. About 9% of the volunteers had a fever. Younger participants were more likely to develop side effects than their older counterparts. There were no reported cases of severe allergic reactions like anaphylaxis.
📍The vaccine’s protective effect was consistent among the different races it was tested on and the different age groups. They also included people with comorbidities, 40.8% of the sample.
📍It appears as if the vaccine also protects against transmission of the virus, as the vaccine had a 74% efficacy against asymptomatic infections. They tested about 1000 participants at 71 days after their vaccination for specific antibodies. This was a sign that they were infected with SARS-COV2, but they never experienced any symptoms.
2 of those that were vaccinated had antibodies showing infection, compared to 16 in the placebo group. These numbers are small, but it’s promising! They are busy following up with a larger group of participants for more data.
📍Vaccine antibody titers stabilized after 71 days, so the immune response gets even more robust as time passes.
📍They also included their sub-study (basically a smaller study within a study), called DART. They gave female rats the vaccine. They did not have any adverse effects relating to their fertility and pregnancy. This is very promising news, meaning the vaccine will probably be safe in pregnancy as predicted.
🆘So why is this an excellent vaccine for SA?🆘
📌It’s a single-shot vaccine. The administration and logistics of getting people vaccinated are just a lot easier. There is no need for people to come for an additional vaccine like the other approved vaccines. More people can also be fully immunized with fewer vaccines; for instance, if we received 1000 vaccines, 1000 people would be fully vaccinated, rather than 500 that would need 2 shots.
📌It’s relatively stable at normal low temperatures. It can be stored in normal refrigeration temperatures for at least 3 months. No need for high-tech ultracold freezers that are needed with the other approved vaccines abroad. This also helps with transportation a ton.
📌The vaccine was tested in South Africa, with South African volunteers (About 5000 of them). The data is close to home. We know it is reliable as it was tested in real-life against our prominent mutated variant.
📌This vaccine significantly decreases the rate of hospital admissions and death. Our healthcare system will breathe a sigh of relief.
📌Having another approved vaccine world-wide means a boost in overall global supplies of vaccines, meaning South Africans can get their hands on vaccines sooner to roll-out to other people other than healthcare workers.
📌The suggested data on the decreased transmission of the virus is SO promising!
🆘Should we worry about the lower efficacy compared to other vaccines?🆘
The Pfizer and Moderna vaccines have an efficacy rate of around 95%, which is fantastic. However, we need to remember that they have a decrease in neutralizing antibodies towards our current mutated variant. This does, however, not mean lower efficacy per se; it will need to be tested further to confirm full efficacy. When we look at the rates of hospitalisations and deaths, they are still really comparable.
The Novavax vaccine only showed a 49% efficacy toward the South African mutated variant. We know the AstraZeneca-Oxford vaccine’s efficacy was also not great (about 10%).
The other vaccines aren’t available in SA yet. The J&J vaccine is available now, and our Healthcare workers are being immunized as we speak, making that the perfect vaccine for SA at the moment.
🆘So what next?🆘
With this great data, the chances of the FDA not approving this vaccine are very low. We will probably hear tomorrow if it is approved, which will then mean widespread roll-out world-wide. Then other regulators will be in line to approve the vaccine.
They will also probably plan further studies on children and pregnant women. J&J also has another massive study underway to see if a second dose of its vaccine works better. If the data indicates this, there might be a booster shot needed later.
Time will tell.
Photo by Daniel Schludi on Unsplash.
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