Results of another vaccine trial will be available in a matter of days

At the moment we have two approved vaccines, the one produced by Moderna and the one produced by Pfizer. Earlier this week there was some disappointing news when Merck announced it was stopping research on two vaccines because testing showed they weren’t very effective.

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Results of Phase 1 clinical studies showed that the two vaccine candidates — known as V590 and V591 — “were generally well tolerated, but the immune responses were inferior to those seen following natural infection and those reported for other SARS-CoV-2/COVID-19 vaccines,” Merck said in a statement about its decision.

But we could be getting some much better news next week when the results of testing on a vaccine being manufactured by Johnson & Johnson become public. Last October the company released some interim data on the vaccine which looked very promising:

The data demonstrate that a single dose of JNJ-78436735 induced a strong neutralizing antibody response in nearly all participants aged 18 years and older and was generally well-tolerated. Immune responses were similar across the age groups studied, including older adults.

The new vaccine has the potential to be a game changer for two reasons. First, unlike the two approved vaccines it can be stored in a regular refrigerator. That greatly simplifies the distribution process. Second, the J&J vaccine only requires one dose instead of two. So instead of making everyone get two jabs two weeks apart, this would be one and done.

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“A single dose would have big logistical implications,” said Michael Haydock, the senior director at Informa Pharma Intelligence. “In terms of the rollout it could really speed things up and simplify things quite considerably.”

The US has ordered 100 million doses and the company has been manufacturing it while it has been testing the vaccine. Typically, companies wait to make the vaccine after its been approved, but that changed during the pandemic.

“Of course, the big question is, will it work?” Haydock said.

We’ll find out if it works next week. If so it will still take a few weeks to get through the FDA paperwork:

If the data from the Phase 3 trial shows that J&J’s Covid-19 vaccine works and is safe, the company will then request what’s known as an emergency use authorization, or an EUA, from the FDA…

With the Pfizer vaccine, it took a little over three weeks from the time the company submitted its data to an EUA. With the Moderna vaccine, it took a little more than two weeks.

If things look good next week, approval will probably be given by the end of February and then J&J can start shipping this out immediately. As mentioned above, they are already producing 100 million doses in anticipation of positive results, all of which are set to be delivered by the end of June. So, realistically, we’re talking about 25 million doses a month from March through June. If that happens, we should be able to blow past President Biden’s revised goal of 1.5 million doses a day.

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There are about 210 million adults (over the age of 18) in the country. We need to immunize about 80-85% to get to herd immunity. So you can start to see how, with three vaccines being pumped out at full tilt, we could get there by summer. Keep your fingers crossed but we could all be looking at something a lot more like the pre-pandemic world by Independence Day.

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David Strom 5:20 PM | April 15, 2024
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