POST 207. October 17, 2021. CORONAVIRUS. “…if you choose your own unauthorized booster shot, what happens if later research proves a different combination is better? That’s why experts say it’s a bad idea to become your own vaccine advisory committee and get a shot out of turn.”

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“On October 15, a key FDA advisory panel voted unanimously to recommend emergency use authorization of a booster dose of Johnson & Johnson’s vaccine for people ages 18 and older, to be administered at least two months after a primary dose. Several panelists said they believe the data suggest the proper course of the vaccine is two doses rather than one.

The FDA will issue a formal ruling on these boosters after weighing the panel’s recommendations. Then the CDC must refine the agency’s recommendations for who should receive the vaccines before rollouts can begin.

The panel is also scheduled to discuss mixing and matching vaccines, following the release of a National Institutes of Health study showing that booster doses of the mRNA vaccines are more effective than a second dose of the Johnson & Johnson shot. FDA officials said that they are not yet ready to put the matter up for a vote.

The Johnson & Johnson news comes a day after the panel voted unanimously to recommend emergency use authorization of booster doses of Moderna’s vaccine for certain populations. This includes all people ages 65 and older as well as those ages 18 to 64 who are at risk of severe COVID-19 because of their underlying conditions. It also includes people ages 18 to 64 who are at high risk of exposure because of where they work or live, such as health-care workers or incarcerated people.” (A)

“While tens of millions of US residents are already eligible for a third jab, Americans across the country remain confused about boosters, who needs them and how they help.

Here’s what we know so far.

What’s the status of each vaccine?

Pfizer

Numbers: To date, more than 103 million US residents have been fully vaccinated with two Pfizer doses, while approximately 7 million have received boosters.

Efficacy: Data shows that a full dosage of the Pfizer vaccine is 88% effective in preventing hospital admission. CDC data released in mid-September shows that the vaccine’s effectiveness falls to 77% after 120 days.

Company Claim About Booster: Pfizer has been supportive of the need for boosters, with CEO Albert Bourla telling reporters that studies have shown that the vaccine’s effectiveness steadily declines to about 84% for vaccinated people four to six months after receiving their second dose.

FDA Ruling: Pfizer boosters have been approved for older adults and 50 to 64 year olds with medical conditions, as well as adults with underlying medical conditions or those who live and work in high-risk settings.

Moderna

Numbers: To date, more than 69 million people have been fully vaccinated with the Moderna vaccine, with about 1.5 million people having received Moderna booster jabs.

Efficacy: New data shows that Moderna’s vaccine was about 93% effective at reducing the risk of being admitted to hospital with Covid-19. It stays about 92% effective after 120 days.

Company Claim About Booster: Last month, Moderna said that a half-dose booster jab would boost antibodies to a higher point than the initial two shots and believes a booster will be necessary “prior to the winter season”. Currently, Moderna boosters have only been approved for certain people with weakened immune systems, such as cancer patients or transplant recipients.

FDA Ruling: On Thursday, a panel of FDA advisers unanimously voted to recommend a single half-dose booster for the elderly, the immunocompromised or those in high-risk jobs or living situations.

The FDA must now make a final decision on whether to authorise Moderna boosters. If authorised by the agency, a panel of CDC advisers will meet to discuss who will receive them.

Johnson & Johnson

Numbers: Nearly 15 million US residents have received a Johnson & Johnson (J&J) vaccine, which is administered in one dose. CDC data shows that only about 9,800 people have so far received J&J boosters.

Efficacy: Research shows that the J&J vaccine is 71% effective in preventing the need for hospital care. After just 28 days, the vaccine’s effectiveness falls to 68%.

Company Claim About Booster: Like Moderna, J&J has submitted a request for emergency use authorisation for its booster jab. In late September, the company said that research shows that a booster provides a nine-fold increase in antibodies. Four weeks later, it had climbed to a 12-fold increase.

FDA Ruling: On Friday, a panel of FDA advisers unanimously voted to recommend boosters for the one-shot J&J vaccine. The panel recommended that boosters be given to anyone over 18, at least two months after the initial dose.

A number of panel members said that J&J should ultimately be considered a two-dose vaccine like Pfizer’s and Moderna’s….”

“Many Americans, however, say they are confused about who can receive the boosters and what the benefits are.

 “Of course, I’m confused. On one day the White House said that they’d give boosters to everyone. It turns out only some people can get them. I still don’t know who decides,”… “It seems to me there’s been a lot of contradictions.”.. (B)

”If mix-and-match boosters are authorized, we might find ourselves with a more bewildering decision: Nine different paths will be available in total, depending on where you started. Assuming that every option will soon be on the table, which one should people take?

Booster shot perplexity is like Abbott and Costello’s “who’s on first?”.. 

https://www.youtube.com/watch?v=sShMA85pv8M (B)

“Can someone get their initial COVID-19 vaccine from one manufacturer and then get a booster from another? The question has intrigued medical professionals since before the first shot went into an arm—and it’s far more than an academic issue. Allowing people to mix and match COVID-19 shots could significantly improve vaccine distribution and may even offer some medical benefits. ..

The NIH embarked on its own mix-and-match research in June, and the interim preliminary results were released online Wednesday. They are now under review by the FDA’s Vaccines and Related Biological Products Advisory Committee…

If the final results of this study, along with others in process worldwide, continue to find advantages, the CDC’s Advisory Committee on Immunization Practices (ACIP) might ultimately green-light a mix-and-match protocol. But it has not done so at this time.

The only combination protocol authorized in the U.S. is for immunocompromised people getting a third mRNA shot to enhance their generally weak response to the first two. The CDC recommends using the same brand throughout, but if that is unavailable, it says a different mRNA vaccine can be used…

Should you try to mix and match?

With the fragmented healthcare system in the U.S., it’s possible that some people here have gotten a second or third dose of a different vaccine through less than legitimate means. You probably know someone who has done this, perhaps swayed by data showing stronger protection for some vaccines or annoyed that boosters for the Moderna and J&J vaccines are not yet approved.

Even though the preliminary NIH results show some advantage, the number of people tested was small. And while no serious adverse events occurred, uncommon reactions wouldn’t be discovered until tens of thousands or more recipients get the combination, Piedra says. It also remains to be seen whether the changes in the immune system seen 15 days after the vaccine ultimately translate into disease protection.

Plus, if you choose your own unauthorized booster shot, what happens if later research proves a different combination is better? That’s why experts say it’s a bad idea to become your own vaccine advisory committee and get a shot out of turn. “Deciding whether to mix,” Javaid says, “should be done in a safe and scientific matter rather than randomly.” (C)

“Here’s what has transpired: On August 18, the CDC and the FDA announced that all Americans who received the two-dose mRNA COVID-19 vaccines should get booster shots eight months after receiving their second dose. That included those who received either the Pfizer-BioNTech or Moderna vaccines, and they were told boosters would be available in September.

But at the time, neither the CDC’s Advisory Committee on Immunization Practices (ACIP) nor the FDA officially authorized booster shots for Americans aged 12 and up. After a recent meeting, the VRBPAC voted that only Americans who are 65 and up, or who have certain underlying health conditions, should get booster shots at this time. The reason, the panel members said, is that there is not yet enough evidence to recommend boosters for younger, healthier people.

Then, the ACIP met on the topic on September 22 and 23, and voted to recommend booster shots of the Pfizer-BioNTech vaccine for people aged 65 and up, along with residents of long-term care settings. Those booster shots should be given at least six months after patients completed their initial two doses of the vaccine, the ACIP said.

This is where things get a little more confusing. Rochelle Walensky, M.D., director of the CDC, overrode the ACIP’s decision and included health care workers, teachers, and others workers in jobs that put them at high risk for COVID-19…

“The final recommendations are “confusing” for people, says William Schaffner, M.D., an infectious disease specialist and professor at the Vanderbilt University School of Medicine…

“At some point, most of us will need a booster,” says Dr. Schaffner. “That happens with a lot of adult immunizations, including the flu vaccine.”

However, COVID-19 vaccines have only been widely available since December 2020 at the earliest, and data is still being collected on how long protection from the vaccines will last.

“There has been a sense that the administration has been very impressed with the data from Israel, which would indicate that immunity is waning,” Dr. Schaffner says. The country has seen preliminary success in giving some of its residents a third dose, which may have provided inspiration for the booster approval by the CDC and the FDA…

“It is true that if you look at antibody levels produced by the vaccine, by eight months, they’re starting to wane,” Dr. Schaffner says. “But antibody levels are an imprecise indicator of protection, and other aspects of protection continue to go on.”..  (D)

“When the vaccines first debuted last winter, Americans were told that each one was excellent, so we should all get whichever of the three was most accessible. If mix-and-match boosters are authorized, we might find ourselves with a more bewildering decision: Nine different paths will be available in total, depending on where you started. Assuming that every option will soon be on the table, which one should people take?

The NIH study tested and compared every possible combination, and here’s the gist: If you need a booster, don’t take J&J. Two weeks after boosting, people who had followed a J&J → Moderna regimen registered average antibody levels that were 9.8 times higher than those who had gotten two J&J shots; antibody levels among J&J → Pfizer recipients hovered just behind. Overall, the highest antibody levels were found among people for whom all three doses were Moderna; Pfizer → Moderna produced the second-highest levels, then Moderna → Pfizer…

The best way to determine which of the nine mix-and-match options produces the best protection from disease would be to recruit thousands of volunteers for a randomized controlled trial, and then count how many people on each regimen get sick over an extended period. But short of doing that, antibody levels provide the best and most convenient information that can be garnered quickly from the greatest number of people.

Omer would like to see such long-term data on clinical outcomes, along with more data on mix-and-match strategies’ effects on different age groups and how long booster protection lasts. These sorts of data are missing from plenty of booster studies, not just mix-and-match. Until we get them, we’ll be stuck where we are right now, knowing more than ever about how to boost, but still unsure of when, exactly, it’s most appropriate to do so.” (E)

“When, exactly, should those people get those shots? Is it better to load up on extra antibodies as soon as possible, or should people wait until COVID rates start to rise again?

Here’s a simple starting point: If you’re already eligible for a third shot because you’re immunocompromised, get it on the sooner side…

Things get squishier for vaccinated people with relatively healthy immune systems. They’ll already be flush with newly minted B and T cells, which lie in wait to produce antibodies and attack the coronavirus. Ali Ellebedy, an immunologist at Washington University in St. Louis, told me that the longer those cells mature in the body, the more prepared they are to fight off the invader. Delivered too early, another dose of the vaccine could end up “restarting something that was already working,” he said. Ellebedy recommended delaying any booster shots by at least six months from your initial course of vaccination. Eight months is better; even a year would be fine…

Ultimately, the dynamics of transmission in your area may be more important than the details of your personal vaccine schedule. David Dowdy, an epidemiologist at the Johns Hopkins Bloomberg School of Public Health, would rather see boosters distributed sparingly and strategically to communities that show signs of an impending surge. While everyone else waits, vaccine makers could update their formulas to better protect against Delta and set up randomized controlled trials to gather better data on how their original doses and boosters are performing.

On an individual level, Dowdy told me, there’s probably minimal harm in eligible people getting third shots now. But vaccine makers might have a new shot in a few months, designed around circulating variants, or even an intranasal option that can stop infections sooner. Once the government announces that tens of millions of people should get a booster now, persuading them to do so again in a few months, when a better option is available, could be difficult. And those who decide to get a booster now might find they’re ineligible for a fourth shot when that better option comes. Case rates might seem scary now, but this pandemic has proved time and again that things can certainly get worse. “I think it’s important to not just say, Should I get a booster or not?” Dowdy said, “but rather, Would I prefer to have a booster now or save the opportunity for later?”” (F)

“The risk of mRNA Covid booster shots causing heart inflammation in young adults continues to worry top scientists weighing whether to approve third doses for anyone over 12, Dr. Ofer Levy, a voting member of the Food and Drug Administration’s advisory panel, said Friday…

The panel previously recommended the FDA approve boosters from Moderna and Pfizer for all seniors and other high-risk groups. But some committee members have voiced concern about authorizing third mRNA doses for people 12 and up due to the risk of two rare heart inflammation conditions, myocarditis and pericarditis.

“As we go into younger and younger age groups, they’re less and less at personal risk of severe Covid, and on the other hand, somewhat more at risk of this inflammatory heart condition with the mRNA vaccine,” Levy told CNBC’s “Closing Bell.” “So it’s a risk benefit analysis, and that’s why you’re seeing that deliberation.”

Though uncommon, myocarditis has been found mostly in male adolescents and young adults who received a vaccine from Pfizer or Moderna, according to the Centers for Disease Control and Prevention. Cases typically arise within days of vaccination, usually after the second dose, and subside with medicine and rest, the CDC said.

Unlike mRNA vaccines from Pfizer and Moderna, J&J’s Covid shot is not associated with a risk for heart inflammation, the CDC says. Over 15 million Americans have received their primary vaccine dose from J&J.” (G)

“The single-dose Johnson & Johnson vaccine that last week won approval from FDA advisers for a booster shot probably should have been a two-shot vaccine from the start, the nation’s top infectious disease physician said Sunday.

“What the advisers to the FDA felt is that, given the data that they saw, very likely this should have been a two-dose vaccine to begin with,” Dr. Anthony Fauci told ABC’s “This Week.”” (H)

As the greenlight looms for another dose of Johnson & Johnson’s Covid-19 vaccine, experts on Friday urged those who received it to get a booster shot as soon as it’s available because it will provide them with the best protection against the coronavirus.

“J&J is a very good vaccine. I also believe it’s probably a two-shot vaccine,” said Dr. Ashish Jha, dean of the Brown University School of Public Health. “It’s really urgent that people get that second shot pretty quickly.

“Probably one is not enough. And everybody who has had one needs a second one two months after the first. They are going to get full protection if they do that,” he said.” (I)

“President Biden announced the donation of 17 million doses of the Johnson & Johnson vaccine to the African Union, a month after President Uhuru Kenyatta of Kenya publicly pleaded for more equitable vaccine distribution around the world.

President Biden on Thursday announced the donation of millions of coronavirus vaccines to a group of African countries during a meeting with President Uhuru Kenyatta of Kenya, which is contending with the pandemic and an unfolding humanitarian disaster in neighboring Ethiopia.” (J)

• A.Here’s the latest on COVID-19 vaccines, BY AMY MCKEEVER, https://www.nationalgeographic.com/science/article/coronavirus-vaccine-tracker-how-they-work-latest-developments-cvd
• B.Covid boosters: Who needs them and how do they help?, By Bernd Debusmann Jr, https://www.bbc.com/news/world-us-canada-58887929
• C.Should you mix and match COVID-19 vaccines? Experts weigh in., BY MERYL DAVIDS LANDAU, https://www.nationalgeographic.com/science/article/should-you-mix-and-match-covid-19-vaccines-experts-weigh-in
• D.What to Know About COVID-19 Vaccine Booster Shots, According to Doctors, By Jake Smith and Korin Miller, https://www.prevention.com/health/a35644466/covid-19-vaccine-booster-shot/
• E.Should You Mix and Match Your Booster Shot?, By Rachel Gutman, https://www.theatlantic.com/health/archive/2021/10/mix-match-booster-covid-vaccine/620395/
• F.You Might Want to Wait to Get a Booster Shot, By Rachel Gutman, https://www.theatlantic.com/health/archive/2021/09/when-you-should-get-your-covid-booster-shot/620123/
• G.Risk of mRNA Covid booster causing heart inflammation in young adults continues to worry scientists, Dr. Ofer Levy says, by Robert Towey, https://www.cnbc.com/2021/10/15/heart-inflammation-risk-in-young-adults-caused-by-mrna-covid-booster-continues-to-worry-scientists-dr-levy-says.html
• H.Fauci says Johnson & Johnson one-shot vaccine should have been two all along: Live COVID-19 updates, by John Bacon and Jeanine Santucci, https://www.usatoday.com/story/news/health/2021/10/17/covid-vaccine-johnson-two-shots-fauci-live-covid-news/8493172002/
• I.J&J vaccine recipients should get their second dose as soon as it’s available, experts say, By Aya Elamroussi, https://www.cnn.com/2021/10/16/health/us-coronavirus-saturday/index.html
• J.Covid News: Biden Announces Vaccine Donation of 17 Million Doses for African Union, https://www.nytimes.com/live/2021/10/14/world/covid-delta-variant-vaccine?referringSource=articleShare
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