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FDA Backs Pfizer COVID-19 Boosters For Seniors, High-Risk

 September 23, 2021 at 11:33 AM PDT

Speaker 1: 00:00 As health officials warn of the possibility of a looming fifth wave of COVID this fall, the issue of waning vaccine effectiveness continues to be front of mind for many Americans just yesterday. The FDA approved a third dose of the Pfizer beyond tech vaccine for seniors and high risk groups. While a CDC approval is expected to provide further guidance within the next few days. However, according to reporting in the San Diego union Tribune, thousands of San Diegans have already sought out their booster shots ahead of official guidance. Dr. Christian Ramers is the assistant medical director with family health centers, and he also sits on San Diego county's vaccine clinical advisory group, and he joins us now, Dr. Ramers welcome back to the program. First, the FDA has approved booster shots for those who are immunocompromised, but the UT is reporting that an estimated 17,000 people who are not immunocompromised may have gotten boosters. What are your thoughts on that? Speaker 2: 00:58 I just want to go through the processes that, that have been set up. You know, these are, I think really cautious and measured ways that we have had very good drug and vaccine safety through this country through many decades. And usually what happens is if the FDA does an extensive review of the data before they change recommendations or before they changed the indications or the labeling of any particular product. And then typically that goes right over to the CDCs advisory committee on immunization practices, which gets much more into the details to give clinicians guidance about what, what is their official recommendation. We realized that, uh, people are desperate and there's a huge demand for people to get booster doses. Uh, mostly because of what's been seen in Israel and the concerns of waning immunity. I would caution people to just have a little bit more patients. Speaker 2: 01:44 We're very, very close to getting a real solid recommendation. And there's a couple of reasons why going out on your own and getting an additional dose might be problematic. Um, the first is that we haven't fully studied all the different combinations and we like to stick to where the data leads us right now. We only have information on the Pfizer booster dose and the FDA has not yet reviewed any other, uh, combinations such as Madrona or the Johnson and Johnson. So we just need to wait until we have more guidance. And secondly, if something, if an adverse event were to occur such as an NFL lactic reaction or, or a vaccine injury, you know, that patient who went out on their own and may have falsified their information to get that third dose or the vaccine provider is kind of out on a limb in terms of liability protections. Speaker 1: 02:26 So what I'm hearing you say is that people should really wait for official guidance from leading health organizations before deciding to get a third shot on their own. Speaker 2: 02:34 Yes, and I want to be clear, what's already been vetted and approved, and that is a third dose for those who are legitimately immunocompromised, that means moderate to severe immunosuppression, either from cancer chemotherapy, from a solid organ transplant or something like that, that's already free and clear and people are welcome to do that in their doctor's offices. Uh, the more recent recommendation which you referred to that the CDC is currently deliberating on with meetings, right, as we speak has to do with their doses, only for those that received Pfizer vaccine. Now I would urge people to be a little bit more patient if they received Madrona or Johnson and Johnson, because that data is being vetted and being reviewed. And there are still many unanswered questions. For example, there's several studies now showing that maternal may, may provide, um, more long lasting protection than Pfizer. And so booster dose may be less necessary. Again, we have to take a look at the data before we can go with those recommendations. Speaker 1: 03:27 You've alluded to this already, but can you tell us a little more about what evidence we have about waning immunity among the already vaccinated? Speaker 2: 03:35 Yeah. It's a complicated question because if you just look at one piece of the elephant, so to speak, which is the easiest to measure antibody levels, you can show that antibody levels are going to decline with time. Now that may be shocking to people, but it's actually a normal process in human immunology. Every that virus and bacteria that you've encountered, you're going to develop antibodies and it's natural for those antibodies to wane with time, if that didn't occur, your blood would be like cement. It would be full of all these proteins. Your body has developed mechanisms in order to flex up and flex down the levels of antibodies. As long as you create immunological memory, that's partially why people who have been fully vaccinated may not be completely protected from infection, but they are very well protected from severe disease because they are able to develop that response very quickly within three to four days of encountering the pathogen again, Speaker 1: 04:24 Um, as we discussed, people are already seeking the booster, but what do you say to patients who were already hesitant to get vaccinated in the first place? And now they're questioning the need for a third? Speaker 2: 04:34 Yeah. I think the message needs to be loud and clear that these shots are, are delivering what they mainly were intended to do. And that is to save lives and to keep people out of the hospital. I think we're debating around the edges about this, whether the series should be two shots or three shots from the get-go and then whether boosters are going to be necessary. But all you have to do is look at the numbers in the county or in the state or in the country to show that unvaccinated people are dying and getting hospitalized at much, much higher rates than those that are vaccinated. That's really the proof of how good these vaccines are actually working at keeping people from getting seriously ill. And I think we should maybe change our expectation a little bit about what the vaccine can deliver. I think it was a little surprised at the beginning to see these numbers of 95% protection from a vaccine. Speaker 2: 05:17 I mean, we were hoping it would be 50% protective, uh, in the beginning, um, in order to be authorized. So the expectation was this is going to create some crazy invisible force field. That's going to protect people from getting infected at all. That's really not realistic. And what we've seen over time is that people can, uh, if they are exposed to COVID, especially with the Delta barrier, which is so much more contagious, if they're exposed and they get the virus in their nose or in their mouth, that they still can Mount a very, very good immune response that protects them from getting very ill. Speaker 1: 05:48 As I mentioned, we are, you know, fearing that we're reaching a fifth wave this fall. I know a lot of family spent the holidays apart last year because of the pandemic. Do you anticipate similar guidance about limiting travel and large indoor gatherings this year? Speaker 2: 06:02 I think this is going to be tough because there is such a desire to get back to the way things were, but we need to ask the public to, to make reasonable decisions about risky, um, contacts essentially. Um, we do have the protection of a, of a large proportion of the population that's been vaccinated. I think what most people are very concerned about is that as it gets colder, people spend more time inside that we're going to see more transmission. And then the twin demic as it's been called, if we have a bad flu year at the same time, as we have a bad COVID year, that's going to be a major problem. So, so public health authorities are really urging us to get flu shots again this year. Um, last year flu took kind of a break because people were on lockdown and not really interacting with each other too much. We've already seen flu transmission start in San Diego county. So I think we're, we're a little bit worried about having that be on top of COVID-19 Speaker 1: 06:52 And speaking with Dr. Christian Ramers assistant medical director with family health centers. Dr. [inaudible]. Thank you so much for joining us today. Speaker 2: 06:59 Thank you so much for having me.

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This is not a done deal yet: The Centers for Disease Control and Prevention has yet to weigh in on who it believes should get boosters and when.
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