COVID-19 Update 5/12: Pfizer Approved for 12-15 & The India Situation

On this COVID-19 update, Dr. Steven Bishop discussed the recent approval for the Pfizer vaccine and children ages 12-15 and touched on the situation in India. Watch the video below or read on for a full recap. 

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Pfizer EUA Approved for Children 12-15

First up is the fact that the Pfizer vaccine, I hate to say the word approved, but it's the emergency use authorization for the Pfizer COVID vaccine has been extended to 12 to 15-year-olds, based on the data that the FDA received from Pfizer.

Now the Advisory Committee on Immunization Practices at the CDC is reviewing all of that data today, and I suspect they'll vote and come up with a decision on that in a couple of hours. (Editor's Note: They did recommend and approve the use.)

And then we'll know if that it's going to become a recommendation for 12 to 15-year-olds to get vaccinated from that committee, I was able to watch part of the meeting this morning. And overall, the safety data that could see and that they presented was pretty good for the 12 to 15-year-olds. It was a small study. There were only 2,200-2,300 12 to 15-year-olds in the study, so it's a fairly small number, actually. But the number of serious adverse events was very minimal.

Nothing that resulted in hospitalization, fatalities, nothing along those lines. Side effects tended to kind of run the usual gamut — fever, chills, body aches, sore arm, that sort of thing, the same thing that you're seeing in adults, but maybe to a slightly lesser extent, in the 12 to 15-year-olds.

Now the issue is that the only metric I could see them reporting on in terms of the efficacy of the vaccine, I have not been able to find the big data dump that Pfizer and Moderna both put out for their adult studies, I haven't been able to find the same thing for the 12 to 15-year-olds yet, and I'm still looking for it. So if somebody has it, and can see it, and has found it, please send it to me.

I'd love to read through the whole thing, but I can't find it. But what they presented this morning was the effectiveness of the vaccine in terms of preventing cases. They saw 18 cases of COVID in the placebo group and none in the vaccinated group.

But they did not report on hospitalizations or fatalities in the vaccinated or placebo groups. My suspicion is there probably weren't any, or there may have been a very small number period, because again, as we know, at this point, the risk to the kids for COVID is pretty minimal. And so I don't think they probably had enough numbers in the trial to really tell if there was a difference in hospitalization rates for these 12 to 15-year-olds. And that's why it's not reported.

But I haven't able to see the big data dump. Hopefully they will release that, so we can all kind of take a closer look at that and see what's going on. But overall it seems safe. In terms of effectiveness, it appears to prevent infection in the 12 to 15-year-old group.

But really the question becomes does it prevent hospitalizations? Is it preventing the small number of fatalities that are out there? And I think that's going to be the thing that people are going to have to weigh when it comes to vaccinating younger and younger people.

Are the potential risks of side effects of the COVID of vaccines, whether it's the Pfizer or the Moderna or whatever, worth taking the risk for just preventing infection if there's also a minimal to zero risk for hospitalization or death in that same person? 

Those are the choices and the kind of things that parents are going to have to weigh in the coming weeks and months as they make these decisions. I hope that they'll dump the rest of that data out so we can all take a look. 

I suspect if that recommendation goes through, and I suspect that it will, then the vaccine will probably be available for 12 to 15-year-olds here in the coming days, and weeks.

My first gut reaction to that is that that's still good news. The more that the vaccine is available for the people who want it, I think that's great. I think there are a lot of kids who probably are going to want to get this and their parents are going to want to get it for them. Those kids who are in higher-risk categories for COVID and a bad outcome from it, even though the data I'm not sure is 100% there for your average risk kid.

But kids with underlying issues like cystic fibrosis, immune system problems, undergoing chemotherapy, or you know, anything like that, where there's an immune system issue, I think this is good news for those types of kids, that the vaccine will hopefully be available for them soon. It's good. And we'll hopefully get a little more data here in the coming days.

The India Situation

What's going on in India? India is a horrible, horrible mess right now with COVID. They are tracking about 300,000 new infections a day, and their fatality numbers have become quite high, unfortunately. And it's really very bad. It's really hard to overstate how bad it is right now.

It is kind of like it was in Italy this time last year, where the healthcare system has effectively collapsed. They have no beds, no oxygen, no medications, hospitals are full. They're turning people away. It's really quite a desperate situation right now in India. And part of what is going on there is they're recording over 4,000 deaths a day. It's pretty bad. '

The variant that has shown up in India is the problem or probably the problem. And the variant that has shown up there is even more transmissible than the highly transmissible variants that we've been seeing in South Africa, in the UK, and other places. That variant is really just spreading like wildfire through the country, unfortunately.

The real problem is going to come for us, and how that may impact us and other countries is, A) if that variant escapes, and B) whether that variant is effectively controlled by vaccines or not.

It appears that that variant may have at least partially escaped from vaccine-induced antibodies, at least from Pfizer, but there's still some activity of the vaccines against the variants. More studies are going to have to come until we know more. But that really is what is going on in India.

Everybody keep India in your thoughts and prayers. And hopefully, the tide will turn there soon. It looks like their numbers are starting to peak. And why that may be is a whole lot of reasons. They are doing vaccination. And so many people are getting infected that they probably will reach herd immunity and the virus transmission levels will start to drop.