FDA Authorizes 3rd COVID-19 Dose For Certain Immunocompromised Patients
August 13, 2021
The Food and Drug Administration is authorizing an additional dose of a COVID-19 vaccine for certain people with weakened immune systems caused either by disease, medical treatments or organ transplants.
The move comes after studies have shown these people may not have sufficient immunity to head off the more serious complications of COVID-19 after the standard vaccine regimen.
Late Thursday night, the FDA amended the emergency use authorizations for both the Pfizer-BioNTech and Moderna COVID-19 vaccines to allow for an additional dose for certain immunocompromised people, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise. The CDC estimates the population to be less than 3% of adults.
"The country has entered yet another wave of the COVID-19 pandemic," said acting FDA Commissioner Dr. Janet Woodcock, noting that immunocompromised people are particularly at risk for severe disease. "After a thorough review of the available data, the FDA determined that this small, vulnerable group may benefit from a third dose of the Pfizer-BioNTech or Moderna Vaccines," Woodcock said.
The Centers for Disease Control and Prevention is convening a meeting of its immunization advisory committee Friday to consider the scientific evidence supporting the FDA's action and whether to recommend the additional dose for these people. The committee will also evaluate more broadly the need for a booster for people who are not immunocompromised.
Some countries have already started administering an additional dose to seniors, based on studies showing a decline in immunity over time. The committee is not scheduled to take any action on the broader question of boosters for the general population.
At a White House briefing Thursday, Dr. Anthony Fauci said there is a need for boosters for these people whose immune systems do not produce a strong response to the regular vaccine regimen. And while he believes that boosters will ultimately be needed for the general population, that time has not arrived.
"We believe sooner or later you will need a booster for durability of protection," he said. "But right at this moment, apart from the immunocompromised ... we do not believe that others, elderly or nonelderly, who are not immunocompromised need [another dose of] vaccine right at this moment."
He emphasized that the government was preparing for that need and would be "ready to do that and do it expeditiously." At the same time, with millions of people around the globe still waiting for their first dose, the World Health Organization is calling for a moratorium on booster shots to help make vaccine distribution more equitable.
https://www.npr.org/2021/08/13/1027296490/fda-authorizes-third-covid-dose-immunocompromised
https://www.cbsnews.com/amp/news/covid-vaccine-booster-shots-pharmacies/#appCVS, Hy-Vee, Jewel-Osco and Walgreens are among the big U.S. pharmacy chains that this week started offering third shots for people who already received their two COVID-19 vaccinations. But only people who are severely to moderately immunocompromised can get the additional shots so far, according to the companies.
The pharmacies said they are following the guidance of the U.S. Food and Drug Administration, which on Friday said that transplant recipients and others with severely weakened immune systems can get an extra dose of the Pfizer or Moderna COVID-19 vaccines. Under that guideline, about 10 million people in the U.S. may qualify for the additional shots now, with roughly 3% of Americans estimated to be immunocompromised.
That means most people will need to wait to get an additional shot amid a surge in COVID-19 cases linked to the highly contagious Delta variant. CVS and Walgreens say they are preparing to administer vaccine boosters to the wider public once they are approved by the the FDA and Centers for Disease Control and Prevention. About 1 in 4 people who have heard about booster shots are worried about waning vaccine protection, the Kaiser Family Foundation found in a recent survey.
On Wednesday, top health and medical experts from the Department of Health and Human Services said the booster shots may start the week of September 20 for people who received their second dose of Pfizer or Moderna vaccines eight months prior.
Here's what to know about the additional shots so far.
What's the difference between an additional shot and a booster shot?
Not much, as the doses are the same, according to University of Chicago associate professor Emily Landon.
The only difference is terminology. A "booster" refers to an extra dose for people whose immune systems responded well to the initial vaccines but might face waning efficacy as time goes on. An "additional dose," meanwhile, refers to the third shot given to people who are immunocompromised and whose immune systems might not have optimally responded to the first two doses, Landon explained.
Who can get an additional shot right now?
Only people who are severely to moderately immunocompromised.
According to the CDC, that includes people who are currently being treated for cancer; have received an organ transplant or are taking immune suppression medications; received a stem cell transplant in the last two years; have a severe primary immunodeficiency; have advanced or untreated HIV infections; or are taking high-dose corticosteroids or other drugs that suppress the immune system.
How can I book a third shot?
Many of the pharmacies say eligible people can either book an appointment online or simply walk in for their third shot.
A Walgreens spokesperson said that same-day appointments are available on a walk-in basis at some of its locations for eligible people. CVS is also offering walk-in appointments (which also may be scheduled online.) Hy-Vee said people can either walk in or schedule an appointment, while Jewel-Osco also is accepting either walk-ins or scheduled appointments.
What do people need to bring?
Pharmacies are recommending that people bring their COVID-19 vaccination record card, but you may also want to check whether your pharmacy requires additional documents. Hy-Vee, for instance, recommends that people bring their insurance or Medicare cards, as well as photo IDs.
Do you need proof of being immunocompromised?
Pharmacies and state health departments say that people should be prepared to self-attest that they are immunocompromised, following federal guidelines.
"According to the CDC, individuals will need to self-attest that they are severely to moderately immunocompromised but do not need to show proof of their condition," Hy-Vee said in a statement.
What does it cost?
The third doses are free, either covered by insurance plans or through a federal program for the uninsured, according to the pharmacies.
What about people who aren't immunocompromised?
The pharmacy chains say they aren't offering booster shots to people who aren't immunocompromised, but plan to be ready once federal regulators give the green light, which is expected in mid- to late-September.
"We will continue to follow guidance from the FDA and CDC to administer vaccines to eligible populations and feel confident we have the pharmacy expertise, infrastructure and local community presence to accelerate access to these vaccinations," Walgreens said in its statement.
someone mentioned that virus shedding wasn't even a thing. Is it a thing? Do vaccinated folk infect other folks? According to 'experts', the vaccines don't stop the person from infecting others. If true, they expect there to be new variants forever and covid will never go away.
How many people are in the hospital due to vaccine side effects?July in Wisconsin-- giving an idea of the relative efficacy of vaccines against the Delta variant even after months of decaying strength (as has been shown in other studies):
How many people are in the hospital due to vaccine side effects?
The possible review comes just two days after U.S. health officials said that COVID-19 vaccine booster doses will be available to Americans from Sept. 20, over concerns that initial vaccinations may offer lower protection in the face of rising infections due to the Delta variant. read more
Health regulators in June had added a warning to the literature that accompanies mRNA vaccines produced by Moderna and Pfizer (PFE.N) to flag a rare risk of heart inflammation seen primarily in young males.
Data from a government agency's safety monitoring system in that month suggested a rate of 12.6 cases of heart inflammation per million in 12-to 39-year-olds. read more
The benefit of mRNA shots in preventing COVID-19 continues to outweigh the risks, regulators in the United States and the EU as well as the World Health Organization have said. read more
Show me the data to back this statement up.Nice try but it ain't this many
Show me the data to back this statement up.
Nice try. You got nothing.Difficult to determine but based on the articles below it can't be anywhere near the death rate for unvaccinated people:
https://www.usatoday.com/story/news...-vaers-death-reports-not-verified/7587577002/
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html
Nice try. You got nothing.
I haven’t really looked into it, have they been giving the third shot to people yet? Are people getting knocked on their ass from it like some did after their second shot?*sigh* I don't want this thread to take a political turn, but the Biden Administration clearly needs a distraction this week.
I'm 100% on board with giving a booster to the immunocompromised and 60+ since that demographic made up most of the severe break-through cases in this wave, but it's so wrong to be wasting millions of bonus doses on our fully-vaccinated general population when the rest of the world is begging for their first dose.
Not to mention it will give the uneducated anti-vaxxers another opportunity to spread fake news about how "vaccines are not effective", despite all the hospitalization data being published weekly across the country that proves them wrong over and over again.
You made statement that you need data to back up and you have none.Your data was also very convincing.
someone mentioned that virus shedding wasn't even a thing. Is it a thing? Do vaccinated folk infect other folks? According to 'experts', the vaccines don't stop the person from infecting others. If true, they expect there to be new variants forever and covid will never go away.
Just in time for Full FDA ApprovalCOVID Booster Shots Are Coming. Here's What You Need To Know
August 19, 2021
https://www.npr.org/sections/health...-shots-are-coming-heres-what-you-need-to-know
Just in time for Full FDA Approval