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FDA OKs Pfizer COVID-19 Vaccine For 12-15 Age Group

 May 11, 2021 at 10:12 AM PDT

Speaker 1: 00:00 The food and drug administration approved usage of the Pfizer vaccine on children ages 12 to 15, expanding the eligibility of vaccine recipients. Now its final approval is up to the CDCs vaccine advisory committee who will hold a meeting tomorrow to review usage of that shot for this new age group, the development comes as a welcome sign for parents and guardians concerned about the effects of COVID-19 on their children. Joining me to discuss the latest on this expanded eligibility is Dr. John Bradley director of the division of infectious disease at Rady children's hospital. Dr. Bradley. Welcome. Thank you so much. So when will vaccinations for this newly expanded age group be available in San Diego County? You think Speaker 2: 00:44 So tomorrow, as you pointed out, the FDA authorized use of vaccine, it's not a full licensure that will come later just like for the adult vaccine, but after the FDA authorizes something, they just say it's safe and effective. Then it's up to another group to recommend its use. And that's where the CDC and their advisory committee on immunization practices comes into play. And they're meeting tomorrow afternoon, East coast, time, morning, Pacific time. So we should get the vote of the committee to recommend that the CDC recommend this vaccine for 12 to 15 year olds by early afternoon in San Diego Speaker 1: 01:26 As a pediatric infectious disease specialist. Are you hopeful that this news Speaker 2: 01:31 I'm much better than hopeful? I'm really happy as you know, kids tend to do okay with growing a virus, they don't get hospitalized at the same rates. And thank goodness we've had not one single death of a child in San Diego since the beginning of the pandemic, but kids can spread it. And as you know, probably half the kids who, who get the infection and can spread it, have no symptoms, which of course just completely took us all by surprise. So in order to get COVID under control in San Diego County and the rest of the state and the United States, we need enough people immunized so that if a virus is introduced from somewhere else, it doesn't continue to spread. That's the herd immunity concept. And of course the other very important goal is that if kids don't get infected, they can't spread it to grandparents and other members of the family who, who are more at risk of serious disease and hospitalization. So there's many different benefits, not even including the fact that they could go out with their friends, if they're all immunized. Speaker 1: 02:42 What did the clinical trials of the Pfizer vaccine indicate about its effect on children Speaker 2: 02:48 Pfizer for this particular FDA authorization included a subset of children between 12 and 16 years of age in their vaccine trials. So they have collected data on a thousand kids, that age group who got a vaccine and compared them with a thousand kids who just got saltwater injections, placebo, and then these kids went out in the community and then you look to see if the vaccine protected these adolescents. And they also of course have full information on safety because they're, they're checking, uh, all of the standard blood tests, uh, symptoms of disease, all of that, uh, as part of a routine post immunization safety check, and the adolescents were just as protected as adults may be even more of, of the thousand kids that got the vaccine. There were no cases of COVID in the thousand kids that did not get the vaccine. There were 16 cases of COVID Speaker 1: 04:00 And you touched on this, but so what are the possible side effects for this age group as a result of getting this vaccine then? Speaker 2: 04:06 So most of the side effects as, as you know, for adults will happen either immediately within the first couple of days. And of course the same cautions for kids we're, we're sharing as cautions for adults. So if you, if you're highly reactive to all kinds of shots and you may be allergic to one of the components of the vaccine, we really don't want you to get this vaccine without talking to your, to your healthcare provider. Uh, and then long-term side effects generally pop up over the first, uh, six to eight weeks where you have persisting muscle fatigue. Uh, you just, you have some reaction to the vaccine and you don't get over it. We are going to continue to look at the multi system, inflammatory syndrome in children, uh, risk that problem. But most of those kids, as you probably know, will get their disease within four to eight weeks of getting the actual infection. And there doesn't appear to be any kid with MIFC following the vaccine. So we think that the benefits of the vaccine and preventing MIFC are far greater than any potential for the vaccine to cause that side effect. Speaker 1: 05:16 Now the expansion of this age group is a huge step towards the nation's overall efforts to inoculate against the virus. At the same time, this news comes as vaccination rates are slowing across the nation. Is this a sign that we're getting closer to a majority of the population being vaccinated? Speaker 2: 05:33 Yeah, I think it's a, it's a reflection that there's probably a group of people who aren't particularly interested in getting back's unaided for, for whatever reason. And we just need to connect with them more. I don't know that we've reached herd immunity. And as a matter of fact, in, in parts of the United States where there are no longer mass mandates and people are all getting together, the virus is spreading, which is that there is no herd immunity yet. And with the new [inaudible] virus, that's now predominant in California, in San Diego that spreads more effectively. So the original prediction that if we had 70% of the people immune, either from vaccine or the infection that the virus wouldn't be able to spread with this new, more contagious mutant, that number is probably higher 75 to 80%. And we're clearly not there, but we need to be so, so I think the slow down has many, many reasons. And I think there are some really well-meaning people who are just cautious. And now that there's a hundred million doses of these MRN vaccines that are out there and safety data on these, I don't think people need to be worried anymore. Speaker 1: 06:45 I've been speaking with Dr. John Bradley director of the division of infectious diseases at Rady children's hospital. Dr. Bradley, thank you so much for joining us. Speaker 2: 06:54 Thanks very much. Appreciate the opportunity to chat with you. [inaudible].

Pfizer said in late March that clinical trials found "100% efficacy and robust antibody responses" to the coronavirus in 12- to 15-year-olds.
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