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Health

Get omicron-specific Covid booster shot by Halloween

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Dr. Ashish Jha has an easy-to-remember deadline for when you should get the new omicron-specific booster shot: Halloween.

“Why Halloween? Because three weeks after Halloween is Thanksgiving, and there’s a lot of travel, and you’re seeing family, and you’re seeing friends — and a few weeks later, it’s the holidays,” Jha, the White House’s Covid response coordinator, said during an episode of the “In the Bubble with Andy Slavitt” podcast on Monday.

“We know respiratory viruses circulate at much higher levels in the fall and winter. It’s a really good time to get yourself protected,” Jha added. “And even if you yourself are on the low-risk side, you’re going to have family and friends you’re going to see. You don’t want to be the person who gives it to your grandma.”

The new shots from Pfizer and Moderna, which target both the original Covid strain and omicron’s BA.5 and BA.4 subvariants, are available to a wide swath of Americans who have received their primary vaccination series.

If you have a high risk of severe Covid, you may want to get the new shot much earlier than Halloween, Jha noted. That includes people who are elderly or immunocompromised, and those with underlying medical conditions.

Likewise, if you only recently got a Covid vaccine or recovered from a Covid infection, you might want to wait a little bit, Jha acknowledged. The CDC says you need to be at least two months out from your last dose of any Covid vaccine, and should consider waiting three months if you’ve recently had the virus.

Covid shots typically take two or three weeks post-injection to ramp up to full protection. That protection tends to last for about three or four months before beginning to wane.

Jha said it’s better to get the new shot sooner rather than later, urging people to avoid waiting until late November and December if they can. The doses will serve as an extra layer of protection that will be badly needed during the fall and winter, when immunity from previous vaccines wanes and people spend a lot more time indoors, he said.

The weather during those seasons also turns the air cold and dry, making it easier for tiny droplets of the virus to survive when people sneeze, cough or talk. New U.S. cases rose to a then-record high in December 2021, with a seven-day average of more than 265,000 per day. The country saw a similar escalating surge in cases in late 2020.

Even if you aren’t worried about getting the virus yourself, Jha said to remember that you can still spread it to high-risk loved ones during fall and winter social gatherings, from Thanksgiving through the winter holidays.

“You don’t want to be the person who gives it to your vulnerable friend who’s immunocompromised,” he said. “Lots of good reasons for people to go get it this fall.”

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Business

Should you wait for an Omicron-specific booster?

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About 50% of eligible Americans have received a booster shot, according to the US Centers for Disease Control and Prevention, but the Pfizer and Moderna news might raise questions regardless. For those who have yet to get inoculated, should they wait until there is an Omicron-specific vaccine? What if someone has already had Covid-19 during the Omicron surge, do they still need a booster? And what does this mean for people who’ve already gotten a booster, or those who received the one-dose Johnson & Johnson vaccine and then subsequently got a dose of another kind?

For answers to these and other questions, I spoke with CNN Medical Analyst Dr. Leana Wen. Wen is an emergency physician and professor of health policy and management at the George Washington University Milken Institute School of Public Health. She is also author of “Lifelines: A Doctor’s Journey in the Fight for Public Health.”

CNN: Should people hold off on getting their booster until they can receive an Omicron-specific one?

Dr. Leana Wen: No, they shouldn’t. Everyone eligible to receive a booster should do so now.

Here are two key reasons why: First, there is growing evidence that a third shot of Pfizer or Moderna or a second vaccine following Johnson & Johnson is needed to sustain strong protection against Covid-19. Last week, three large new studies from the CDC found that boosters protect against severe illness and reduce the likelihood of contracting coronavirus.

During a period in December and January when Omicron was dominant, one study found that getting a booster dose was 90% effective at preventing hospitalization, compared with the 57% effectiveness seen in vaccinated people who had not been boosted and were six months past their second shot. Another study examining over 13,000 Omicron cases found that the likelihood of developing symptomatic infection was 66% lower in participants with three doses compared with two.

Second, the Omicron-specific vaccines are still in clinical trials. The trials will take months complete. We don’t know yet the results of the trial and whether these variant-specific vaccines will be better than the original vaccines. Even if they end up getting authorized, it will be months from now, and with Omicron still surging, people shouldn’t delay their boosters.

If you are an adult at least five months out from your two doses of Pfizer or Moderna, or two months out from your one dose of Johnson & Johnson, you should get a booster now. Adolescents 12 and older are also recommended to receive a third dose of the Pfizer vaccine if it’s been at least five months since their second dose (only the Pfizer/BioNtech vaccine is authorized for adolescents 12 to 17).

CNN: If you get the regular booster now, does that mean you can’t get the Omicron-specific booster later?

Wen: No. One of the groups Pfizer is studying includes individuals who received three doses and now are receiving a fourth vaccine dose that is an Omicron-specific booster. The company will be studying the effect of this fourth dose. It may be that a fourth shot isn’t needed because the initial booster will continue to provide very good protection. But if the variant-specific booster, in addition to the third dose, is something that adds a lot more protection, the recommendation may well be that people receive it in the future.

CNN: What if someone has just had Omicron? Should they still get the regular booster now?

Wen: Most people don’t find out what variant of Covid-19 they had if they were infected, but given that Omicron now constitutes over 99% of new infections, if they recently contracted the coronavirus, it probably was Omicron.

Individuals who are vaccinated and also recovered from infection appear to have a very high degree of immune protection. The immunity from recovery is variable, though. Someone who became very ill may have a stronger antibody response compared with someone who had an asymptomatic infection, and we don’t know how long that immunity lasts.

That’s why boosters are still recommended for people who have had Covid-19. They can receive one as soon as their isolation period ends, as long as they no longer have a fever and their symptoms are improving.

CNN: How long does the booster last? Do you think we will need a second booster soon?

Wen: We don’t know. A new pre-print study from the University of Texas, online but not yet peer-reviewed, found that antibodies against Omicron remain robust four months after the booster dose. There are also other components of the immune response, T-cells and B-cells, that may remain strong for months, too, but we just don’t know yet when immunity after three shots may wane. This is something that researchers will monitor very carefully. In the meantime, the evidence is very clear that people need to receive that booster dose.

CNN: What about people who initially received the Johnson & Johnson vaccine, and then subsequently got their booster? Do they need a third shot?

Wen: I’m one of these people — I initially received the one-dose Johnson & Johnson vaccine in a clinical trial and then decided to “mix and match” and got a Pfizer booster.

I don’t think those of us who have received a second dose of any of the vaccines (Pfizer, Moderna or J&J) following the initial J&J shot need to receive a third shot at this time. A study out of South Africa found that a second dose of J&J was 85% effective against hospitalization during a time when Omicron was circulating, compared with 63% after one dose. Another real-world study from the United Kingdom looked at the AstraZeneca vaccine, which is similar to J&J.

It found that while two doses of AstraZeneca provided little protection against Omicron, a Pfizer booster following AstraZeneca resulted in 71% protection against symptomatic illness. This was a similar level of protection to those who received three doses of the Pfizer vaccine.

At the moment, the recommendation is that those of us in the US who received J&J initially are fine with a second dose of any of the three authorized vaccines. I am not planning to get a third vaccine dose any time soon. However, I do think there’s been a sense that federal health guidance has lagged for J&J recipients, and I hope there will not be a delay in advising us should research come out that a third dose is needed.

CNN: Do you think the development of Omicron-specific vaccines will help with speeding up the end of the pandemic?

Wen: I am optimistic, in general, about the Covid-19 pandemic coming to an end. Not that Covid-19 is going to disappear — it’s something that’s almost certainly going to be with us for the foreseeable future — but we have many more tools that will allow us to coexist with the virus so that it doesn’t have to dominate our lives.

Developing new vaccines will be a key part of living with Covid-19. I hope there will be more research into vaccines that target coronaviruses broadly, so that if new mutations arise, we don’t need to keep playing Whack-a-Mole.

That said, I do think it’s a good thing that companies are developing variant-specific vaccines, especially if they end up providing better, more robust protection. Again, though, we won’t know whether that’s the case for months, and people should really not delay getting their boosters now.

This story has been updated to include additional information about Moderna’s clinical trials.

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Moderna vaccinates first participant in phase 2 trial of Omicron-specific booster as study finds that antibodies fall 6-fold over 6 months

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“We are reassured by the antibody persistence against Omicron at six months after the currently authorized 50 μg booster of mRNA-1273. Nonetheless, given the long-term threat demonstrated by Omicron’s immune escape, we are advancing our Omicron-specific variant vaccine booster candidate and we are pleased to begin this part of our Phase 2 study,” CEO Stéphane Bancel said in a news release. “We are also evaluating whether to include this Omicron-specific candidate in our multivalent booster program.”

Moderna promises to share its data from the trial with public health leaders so they can make evidence-based decisions on the best booster strategy against the coronavirus going forward.

Omicron currently accounts for 99.9% of US Covid-19 infections, the US Centers for Disease Control and Prevention said Tuesday. The Delta variant makes up the remaining 0.1%.

A study published Wednesday says the Moderna Covid-19 booster shot remains durable against the Omicron variant, but the antibody protection wanes and is six times lower six months after getting boosted.

The study, published in the New England Journal of Medicine, also found that the neutralizing antibody levels declined against the Omicron variant much more rapidly than against the dominant strain of the virus that was circulating two years ago.

Research teams from Moderna, Duke University, Emory University, the Fred Hutchinson Cancer Research Center, the Baylor College of Medicine, the University of Maryland School of Medicine and the National Institutes of Health looked at blood samples from adults who had two doses of the Moderna vaccine, as well as those who also had a booster dose. Some of those were boosted with the 50-microgram dose and some at 100-μg levels. The current booster is authorized at the 50-μg level.

With the primary two-dose regimen, the Moderna vaccine generated neutralizing antibodies against the Omicron variant in 85% of the people in the trial one month after the second dose.

Seven months after the participants got their second dose, neutralization against Omicron was detected in only 55% of the blood samples.

A 50-μg booster dose improved the durability of neutralization at 20 times higher than the levels seen in those who just got two doses of the vaccine.

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Pfizer and BioNTech begin clinical trial for Omicron-specific vaccine

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The study will evaluate the vaccine for safety, tolerability and the level of immune response, as both a primary series and a booster dose, in up to 1,420 healthy adults ages 18 to 55.

Participants in the first cohort have received two doses of the current Pfizer Covid-19 vaccine at least 90 to 180 days before the study. They will receive one or two doses of the Omicron-specific vaccine.

Participants in the second cohort have received three doses of the current Pfizer Covid-19 vaccine at least 90 to 180 days prior to the study. They will receive one dose of the current Pfizer Covid-19 vaccine or the Omicron-specific vaccine.

Participants in the third cohort have not received any Covid-19 vaccine. They will receive three doses of the Omicron-specific vaccine.

The Omicron-specific vaccine will be administered as a 30-microgram dose, the same as the current vaccine.

“While current research and real-world data show that boosters continue to provide a high level of protection against severe disease and hospitalization with Omicron, we recognize the need to be prepared in the event this protection wanes over time and to potentially help address Omicron and new variants in the future,” Pfizer Senior Vice President and Head of Vaccine Research and Development Kathrin Jansen said in the release.

Pfizer CEO Albert Bourla said last month that if a new vaccine is needed for the Omicron coronavirus variant, the company will have one in March. However, a Pfizer spokesperson confirmed that the company has already begun to manufacture this vaccine.

“In the wake of Omicron, we are proactively investigating and manufacturing at risk an Omicron-based vaccine should it be needed, but we of course need to have results and discussions with health authorities as well as approvals before it would be deployed,” the spokesperson told CNN.

Expected vaccine production will not be affected if the companies need to pivot to the new vaccine, they said.

“The companies have previously announced that they expect to produce four billion doses of the Pfizer-BioNTech COVID-19 Vaccine in 2022, and this capacity is not expected to change if an adapted vaccine is required.”

However, the companies also emphasized that people who have received booster doses of the current vaccine “maintain a high level of protection against Omicron, particularly against severe disease and hospitalizations.”

A new preprint lab study suggests that antibodies against the Omicron coronavirus variant remain robust four months after a third dose of the Pfizer/BioNTech vaccine.

“Additional real world effectiveness data and laboratory investigations will further inform the duration of protection, potential need for an additional dose at a later time, and whether an Omicron modified vaccine is required,” said the study from researchers at the University of Texas Medical Branch, Pfizer and BioNTech.

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Fauci says omicron-specific vaccines may not be needed, while new research indicates T-cell protection may hold up against the variant

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It’s becoming clear that much of the concern about the omicron variant has to do with how much it will cut into the protection provided by the COVID-19 vaccines.

New details about omicron have emerged this week that indicate the variant may not cause more severe disease but is likely much more infectious than the delta variant. This means that even those who are fully vaccinated may be at higher risk for contracting this variant than other forms of the virus.

With little science to go on right now, there has been a wide range of responses to the few details we have so far about omicron.

Pfizer CEO Albert Bourla this week said a fourth dose of its COVID-19 vaccine could be needed, within a year of getting the third shot. A headline in The Atlantic says “The pandemic of the vaccinated is here.” And this is why health officials continue to push people who are fully vaccinated to get a booster shot of any COVID-19 vaccine. (Teens who are 16 and 17 years old can now get BioNTech
BNTX,
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and Pfizer’s
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booster.)

“Although we don’t have all the answers on the omicron variant, initial data suggests that COVID-19 boosters help broaden and strengthen the protection against omicron and other variants,” Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, said in a statement on Thursday.

Vaccines and natural infection can create immunity through different avenues, including T-cells and antibodies. The worry has been that omicron might be able to evade these protective antibodies.

However, new research says that people who have generated a T-cell response through COVID-19 vaccination or infection may still be protected against omicron, though it’s unclear to what degree, according to a new preprint, which is preliminary medical research that has not been peer-reviewed.

“SARS-CoV-2 has not evolved extensive T-cell escape mutations at this time,” concluded the study’s authors, who include scientists at the National Institute of Allergy and Infectious Diseases and Johns Hopkins Medicine. 

(“Good news,” tweeted Dr. Isaac Bogoch, a University of Toronto infectious diseases physician.)

And if existing vaccines, including boosters, can hold up against omicron, that may mean we won’t need a variant-specific COVID-19 vaccine.

“If you look at protection against variants, it appears to relate to the level of immunity and the breadth of the immunity that any given vaccine can instill on you,” Dr. Anthony Fauci, the president’s chief medical advisor, said in an interview with STAT.

Here’s what else you should know about COVID-19 

Ten percent of Americans believe that the COVID-19 vaccines conflict with their religious beliefs, according to a NPR story about a new survey from the Public Religion Research Institute and the Interfaith Youth Core. 

About 50 million in the U.S. who have been sick with COVID-19 still have persistent symptoms, including severe fatigue, in cases that are known as long COVID, according to The Washington Post. Some have to quit their jobs, others are racking up debt, and experts estimate that between 750,000 to 1.3 million people can no longer work full time. 

The latest COVID-19 numbers

The daily average case count in the U.S. was 119,788 on Thursday, down from 121,311 on Wednesday, but overall the case count was still up 30% from two weeks ago, according to the New York Times tracker. The daily average death toll was 1,281 on Thursday, compared with 1,275 on Wednesday, and is up 18% from two weeks ago. Hospitalizations increased to a two-month high of 62,971.

The number of fully vaccinated people in the U.S. rose to 200.7 million, or 60.5% of the population, according to data from the Centers for Disease Control and Prevention, while the number of people receiving booster shots rose to 49.9 million, or 24.9% of the population.

The number of new cases in South Africa continues to sharply rise, with 22,391 new cases on Thursday, according to the National Institute for Communicable Diseases there. Only 22 deaths were reported on Thursday.  



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CDC director confirms FDA in talks to streamline authorization of omicron-specific vaccine

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The director of the Centers for Disease Control and Prevention confirmed on Sunday that the Food and Drug Administration was in discussions to streamline the authorization of an omicron-specific vaccine.

“You know, one of the things about a booster – about a variant-specific booster – I know Moderna, Pfizer, Johnson and Johnson say they can all do this fairly quickly within three months. But then you have FDA approval. Is there any world where you can see that moving much faster given we’ve already been through this?” “This Week” co-anchor Martha Raddatz asked CDC Director Rochelle WalenskyRochelle WalenskySunday shows preview: Multiple states detect cases of the omicron variant CDC working to tighten testing requirement for international travelers Overnight Health Care — Presented by March of Dimes — Omicron sets off a flurry of responses MORE on ABC.

“Yeah, you know, much of that I would have to defer to the FDA, but they’re already in conversations about streamlining the authorization of this, of an omicron-specific vaccine, partially because much of the vaccine is actually exactly the same and really, it would just be that mRNA code that would have to change,” Walensky answered.

“So those conversations are ongoing, and certainly, FDA will move swiftly and CDC will move swiftly right thereafter,” she added.

Walensky’s comments follow a report by The Wall Street Journal last week that indicated the Food and Drug Administration was eyeing steps for a rapid review of drugs and vaccines specific to the omicron variant in the event that new variant-specific tools were needed.

Among some of the considerations that FDA is reportedly eyeing would be allowing drugmakers for studies, in the case of vaccines, to examine hundreds of people and their immune responses in comparison to COVID-19 test trials that rely on waiting for COVID-19 to be detected and include thousands of participants, according to the newspaper.

In response to an inquiry about the report by the Journal, the FDA pointed to a statement last week by the acting commissioner Janet Woodcock for the “​​FDA’s latest thinking on vaccine development to address variants” in addition to the agency’s vaccine emergency use authorization guidance last updated in February.

“Historically, the work to obtain the genetic information and patient samples for variants and then perform the testing needed to evaluate their impact takes time. However, we expect the vast majority of this work to be completed in the coming weeks,” Woodcock said last week.



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