FDA authorizes second coronavirus booster shot for people 50 and older
Source: Washington Post
The Food and Drug Administration on Tuesday authorized a second booster shot of the Pfizer-BioNTech and Moderna coronavirus vaccines for people 50 and older, a decision intended to help shore up protection against severe illness.
The shots, which can be given at least four months after a first booster dose, are not a permanent solution to the pandemic. But with a still-more-transmissible version of the omicron coronavirus variant becoming dominant in the United States, even a short-term immunity boost among those at risk of severe illness could provide a valuable layer of protection.
The second booster is expected to become available immediately after the Centers for Disease Control and Prevention reaches a decision on who should get it.
The CDC is expected to say that people in the age group may get a fourth shot, instead of an explicit recommendation that they do so, a reflection of the ongoing debate about the benefits of additional doses and uncertainties about the future of the pandemic. The agency is also expected to highlight vulnerable populations within the age group who may get the shot.
Read more: https://www.washingtonpost.com/health/2022/03/29/fda-authorizes-second-booster-shot/
Once CDC signs off, then it will be a done deal. It was already authorized for certain ages and conditions previously.
Here is the FDA Press Release - https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-second-booster-dose-two-covid-19-vaccines-older-and
Coronavirus (COVID-19) Update: FDA Authorizes Second Booster Dose of Two COVID-19 Vaccines for Older and Immunocompromised
For Immediate Release: March 29, 2022
Today, the U.S. Food and Drug Administration authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for older people and certain immunocompromised individuals. The FDA previously authorized a single booster dose for certain immunocompromised individuals following completion of a three-dose primary vaccination series. This action will now make a second booster dose of these vaccines available to other populations at higher risk for severe disease, hospitalization and death. Emerging evidence suggests that a second booster dose of an mRNA COVID-19 vaccine improves protection against severe COVID-19 and is not associated with new safety concerns.
The agency amended the emergency use authorizations as follows:
A second booster dose of the Pfizer-BioNTech COVID-19 Vaccine or Moderna COVID-19 Vaccine may be administered to individuals 50 years of age and older at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine. A second booster dose of the Pfizer-BioNTech COVID-19 Vaccine may be administered to individuals 12 years of age and older with certain kinds of immunocompromise at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine. These are people who have undergone solid organ transplantation, or who are living with conditions that are considered to have an equivalent level of immunocompromise. A second booster dose of the Moderna COVID-19 Vaccine may be administered at least 4 months after the first booster dose of any authorized or approved COVID-19 vaccine to individuals 18 years of age and older with the same certain kinds of immunocompromise.
“Current evidence suggests some waning of protection over time against serious outcomes from COVID-19 in older and immunocompromised individuals. Based on an analysis of emerging data, a second booster dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine could help increase protection levels for these higher-risk individuals,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Additionally, the data show that an initial booster dose is critical in helping to protect all adults from the potentially severe outcomes of COVID-19. So, those who have not received their initial booster dose are strongly encouraged to do so.”
Today’s action applies only to the Pfizer-BioNTech and Moderna COVID-19 vaccines and the authorization of a single booster dose for other age groups with these vaccines remains unchanged. The agency will continue to evaluate data and information as it becomes available when considering the potential use of a second booster dose in other age groups.
The FDA-authorized Pfizer-BioNTech COVID-19 Vaccine and the FDA-approved Comirnaty can be used to provide the authorized booster dose(s). Similarly, the FDA-authorized Moderna COVID-19 Vaccine and the FDA-approved Spikevax are authorized to provide the authorized booster dose(s).
Information to Support Authorization of a Second COVID-19 Booster Dose
The FDA has determined that the known and potential benefits of a second COVID-19 vaccine booster dose with either of these vaccines outweigh their known and potential risks in these populations. The evidence considered for authorization of a second booster dose following primary vaccination and first booster dose included safety and immune response information provided to the agency as well as additional information on effectiveness submitted by the companies.
A summary of safety surveillance data provided to the FDA by the Ministry of Health of Israel on the administration of approximately 700,000 fourth (second booster) doses of the Pfizer-BioNTech COVID-19 Vaccine given at least 4 months after the third dose in adults 18 years of age and older (approximately 600,000 of whom were 60 years of age or older) revealed no new safety concerns.
The safety of Moderna COVID-19 Vaccine, when administered as a second booster dose, is informed by experience with the Pfizer-BioNTech COVID-19 Vaccine and safety information reported from an independently conducted study in which the Moderna COVID-19 Vaccine was administered as a second booster dose to 120 participants 18 years of age and older who had received a two-dose primary series and a first booster dose of Pfizer-BioNTech COVID-19 Vaccine at least 4 months prior. No new safety concerns were reported during up to three weeks of follow up after the second booster dose.
Immunogenicity data from an ongoing, open-label, non-randomized clinical study in healthcare workers at a single center in Israel were reported in a publication provided to the FDA. In this study, individuals 18 years of age and older who had received primary vaccination and a first booster dose with Pfizer-BioNTech COVID-19 Vaccine were administered a second booster dose of Pfizer-BioNTech COVID-19 Vaccine (154 individuals) or Moderna COVID-19 Vaccine (120 individuals) at least four months after the first booster dose. Among these individuals, increases in neutralizing antibody levels against SARS-CoV-2 virus, including delta and omicron variants were reported two weeks after the second booster as compared to 5 months after the first booster dose.
The amendments to the EUAs to include a second booster dose for these populations were granted to Pfizer Inc. and ModernaTX Inc.
= new reply since forum marked as read
.webp
are a "new and improved" formula and seems to work best on other members of the household -
But still complains that the drug companies are making a fortune. So greed, to him, is the driving factor of these vaccines. Not endng pandemic.
And with the booster for teens, it was NEARLY A WEEK after CDC 
Nevertheless, once that happens, I will, again, be there the first day.
where the earlier request by Pfizer (and probably Moderna) was to drop down to "60" vs the "50" that was chosen by FDA - MAINLY because many POC experience underlying health conditions under 60 age and continue to be left out of disease-fighting care because of those types of age cutoffs.
It was something mentioned in the other LBN OP I posted - https://www.democraticunderground.com/10142895702
Regarding the cost - I know they were saying they were running out of funds but then like the "debt ceiling" and when the exact date happens for a "default", I don't think they have yet gone down to the penny for calculating exactly WHEN they are going to run out - and mainly because there was an assumption about some large "X%" of people who were assumed would be boosted and that didn't happen - let alone getting the younger age groups through their first doses.
PLUS you have the potential for doing logistics tweaks to move already paid-for doses to locations that could use them as long as the storage requirements can be met.
So if anything, we have to see what it comes down to with respect to funds (including whether they separated out the costs for treatments like the monoclonal antibodies and antiviral pills vs vaccines).
(whether from the federal/state/local health officials) since they most likely need to program in any new authorization codes to their systems for tracking and reimbursement. So that might be something that goes directly to the corporate offices who then communicate the codes/guidance to their retail stores (at least for the big chains).
Plus those actually controlling the vaccine distribution (usually the states but in some cases like here in Philly, the city gets it directly from CDC allocations) need to update their inventory status so that the doses are available to the providers as needed.
So definitely give it a day or so.
since the Riteaid I normally go to that does my scripts ended up with all of their local retail pharmacies having some sort of "system glitch" that rejected city residents and only allowed scheduling for suburbanites (and there were news articles that published stories of people requesting appointments describing the exact same criteria in their appointment request (age/occupation/health issues) and getting rejected if they input a city address and zipcode ).
I did get my first booster at my usual Riteaid back in November with no problem by using their "walk in" option (where they accepted walk-ins for 1 hour each day - 2 pm - 3 pm (and since I'm retired, that was perfect). Was in, got my booster and my flu shot at the same time, waited the requisite 15 minutes for any adverse reaction, and was done.
From what I keep hearing in the news, many who were eligible for the last booster still haven't gotten it and I expect even among the boosted crowd, they might not bother with yet another one (I know when I mentioned to some of my cousins last night who are vaxxed and boosted, they were non-committal despite being eligible). So I don't think the gigantic crowds seen with the initial booster offerings, are going to be there this go-around.
that recently went purple and has gotten more and more blue but they never imposed the mask mandates to the degree that they did here in Philly, so whenever I had gone there to shop (their sales tax is 2% less than here in the city that had 2% tacked onto the state's 6%), few if any were masked and still aren't. I have kept my trips very very localized and try to get in and out as fast as I can.
I guess maybe a good indicator here is that I have yet to get any "free masks" because they are always out of them when I have checked (they had even printed out and posted signs that said that they were "out of stock" for them). 
Will still keep checking though because it is always good to have backups. I have a small stash of N95s (that I re-use a couple times since I don't use them more than about 90 minutes at a time and rotate a fresh one in before going back to an earlier one), some KN95s, and a couple boxes of surgical masks (along with some form-fitting cloth ones with bendable nose bands to double-mask with the surgicals).
And yup - sounds like you were the first one of the day so you had to wait for them to get everything setup. Since they are apparently offering vaccines from each of the different manufacturers, they probably needed to make sure all of them were diluted and ready to go and/or they would have enough of each type prepped for any later appointments since people can request a specific one. Plus you have a circumstance where the Moderna (now called "SpikeVax" since they got their BLA approved in January) "normal booster" is actually 1/2 a regular dose, with immunocompromised approved for a full 3rd or 4th dose otherwise, and then they need to confirm they also have enough for and estimated number of walk-ins for the day.
I know you are relieved!!!! Hope you have minimal side-effects going forward. 
within minutes after the shot while waiting the required 15 minutes. Got that shot on a Wednesday and along with the sore arm, the fatigue hit by that Saturday and I slept for a bunch of hours "extra" than I normally do and was a little light-headed when I woke up and moved around. No fever though but more like what it's like when you get a bad cold. It was all gone by that next day.
Second dose triggered little or no symptoms other than the sore arm lasting longer than the first time, and with the booster, it was nada - and that was with me getting the flu shot at the same time (one in each arm)! I guess my body was like - "okay okay already... sheesh!"
I've been in this family's hands since I got married at 25. My present Dr. is the son of my original Doctor. I have everyone in my family seeing him now as well.
He's a firm believer of Medicare for all and has lectured all over the country in it's advocacy. That includes The Harvard Club, John's Hopkins, Stanford U. etc. etc.
In an age when most Doctors are out for nothing but money, this Doctor - who could be making millions in a city larger than Rochester, NY - sees the homeless, poor, rich, and everyone in between. I am truly blessed to have this man guard my health.
There are a few websites that are patient reviewed, so if you want the story on a specific Doctor in your area they're very helpful. One I can suggest and I've used before to rate Doctors is www.healthgeades.com
Good luck to you, wnylib. I hope you can find a Doctor better than your current quack. I can't believe a Doctor actually told you that "COVID is no big deal", especially at our age. Good luck to you.
of having an abundance of Doctors available to all socioeconomic clients. It's a very caring city, even though Monroe County goes red in most elections. The City votes blue, but the suburbs are either purple or red.
We're also blessed to have the Open Door Mission taking care of the homeless, and DePaul social services to help the working poor. Rochester has the same problems of any city, but they also have enough good people who care.
Rochester is a pretty cool place to be from. Hope wherever you live now measures up to your hometown.
the head of the nursing department at the U of R. She would have been retired by the time you started your studies though.
I know Greece well. I had a lot of friends who lived there. We live a little farther west, in Hamlin, right on the lake.
There's always something going on in Rochester. Festivals for everything under the sun, professional baseball, soccer, lacrosse, hockey teams, plus all sorts of college activities. The city has a two week long "Fringe Festival" in September, that has become the largest interdisciplinary festival in New York State. Alternative music, art, performers from across the nation come and perform at 15 different venues. There's some incredible stuff there. It's almost like a two week long mini-burning man hosted in Rochester.
Anyway, glad you and the family are doing well in your Chicago area home. Stop by Rochester if you're ever in New York. It's probably changed a lot since the last time you were here. Take care.
Got this headline on my phone, so thanks for the details - it'll be a couple of weeks for me before it's 4 months, but now I need to speak to my "How many more do I have to get?!" brother...
So it's now "officially" good to go having both agencies give the green light...
And I guess I don't blame your brother.
It's eventually going to be at least annual (or perhaps biannual until they can tweak it a bit more).
I got my booster in November so I am at the 4 month mark now although I was thinking maybe to wait for 5 months (the original guidance) since I have been doing Moderna (now officially called "SpikeVax" ) and that efficacy seems to last longer. That way I could maybe time any additional shot at "6 months" to get boosted right before the holidays.
And thanks for the advice/suggestion - I got all mine at CVS since that's the first place that offered the vaccine in these parts. I got my booster nearby, but had to go to Saratoga to get my first two shots since the local pharmacies were immediately overwhelmed as soon as the news got out that they were offering it.
My brother got the Pfizer at a state-run clinic in the old Sears store at the local mall which is just down the road, so he actually went back on his own to get his booster (after I nagged him). Last I knew, that clinic was still in operation, have testing and vaccines on alternate days, so I'm hoping that continues because he's more likely to go back to the same place. *sigh*
I definitely agree that going to the same place and/or to a familiar place close by is definitely recommended!
To show me that he'd gotten his booster! I try not to nag, but I knew how essential it was for him to get vaccinated to begin with. But my brother is agoraphobic, doesn't leave the house unless he absolutely has to - I took him to get his first two shots, so I was pleasantly surprised when he showed me he'd gotten his booster. And he did ask me when I initially brought up the booster how many he'd have to get so I'm not looking forward to telling him a fourth shot is suggested. He got his booster on December 16th, so I have time to work up to it. *sigh*
That's great that he at least took that initiative knowing how stressful it could be doing it but he was able to weigh the risk to the benefit and get it done. 
You could always tell him that we are in a "new year" and it wouldn't have to be "back to back" shots like the first time anymore.
