Fourth vaccine shot not effective at preventing Omicron infection, Israeli study finds



Preliminary research from Israel suggests that a fourth COVID-19 mRNA vaccine booster shot may be ineffective against breakthrough infection from the Omicron variant.

The authors of a study that looked at the effectiveness of a fourth Pfizer-BioNTech or Moderna shot against Omicron said they were releasing data early on Monday to keep the public up to date with the latest developments in vaccine research.

“Despite a significant increase in antibodies after the fourth vaccine, this protection is only partially effective against the Omicron strain, which is relatively resistant to the vaccine,” Dr. Gili Regev-Yochay, the lead researcher on the study, told reporters Monday.

The study included 154 health care workers at Sheba Medical Center who received their fourth Pfizer shot. Another 120 workers received a fourth dose of the Moderna vaccine, and a control group of 6,000 workers were not given a fourth booster shot of either vaccine.

Regev-Yochay said that a third shot resulted in "much higher antibodies, neutralization and the antibodies were not just higher in quantity but also in quality" than the second shot — but the fourth shot did not produce similar results.

"These are very preliminary results. This is before any publication, but we're giving it out since we understand the urgency of the public to get any information possible about the fourth dose," Regev-Yochay explained.

"We have a follow-up of the Pfizer vaccine for two weeks now, and we have a follow-up of the Moderna vaccine just for one week at this time point. And what we see is that the Pfizer vaccine, after two weeks, you see an enhancement or increase in the number of antibodies and neutralizing antibodies — a pretty nice increase. It's even a little bit higher than what we had after the third dose," she said. "Yet, this is probably not enough for the Omicron."

Regev-Yochay added that slightly fewer infections were observed among those who got the fourth vaccine shot compared to the control group, which may indicate there's a small benefit to letting the people most vulnerable to COVID-19 get a fourth booster.

"I think that the decision to allow the fourth vaccine to vulnerable populations is probably correct," she said. "It may give a little bit of benefit, but probably not enough to support the decision to give it to all of the population, I would say."

International bodies are warning governments and public health authorities against requiring a fourth vaccine shot. At a press briefing last week, the European Medicines Agency said there was no need for a second booster, even warning that repeated vaccine doses could actually weaken people's immune systems.

Boosters “can be done once, or maybe twice, but it’s not something that we can think should be repeated constantly,” Marco Cavaleri, the EMA head of biological health threats and vaccines strategy, said, according to Bloomberg.

“We need to think about how we can transition from the current pandemic setting to a more endemic setting,” Cavaleri added.

The EMA advised countries to leave more time between booster programs and to tie them to the cold season on each hemisphere.

The World Health Organization has also warned that repeated booster doses of COVID-19 vaccines are "not a sustainable global strategy," raising concerns about the supply of vaccine doses.

“With near- and medium-term supply of the available vaccines, the need for equity in access to vaccines across countries to achieve global public health goals, programmatic considerations including vaccine demand, and evolution of the virus, a vaccination strategy based on repeated booster doses of the original vaccine composition is unlikely to be appropriate or sustainable,” the WHO said last week.

Pfizer CEO: Fourth dose of COVID vaccine may be needed sooner than expected because of Omicron variant



Pfizer CEO Albert Bourla said a fourth dose of the COVID-19 vaccine may be needed sooner than expected because of the Omicron variant.

Bourla previously projected that a fourth shot might be needed 12 months after the third dose. However, he announced on Wednesday that the Omicron variant could accelerate the timeline for a fourth dose.

"With Omicron we need to wait and see because we have very little information. We may need it faster," Bourla told CNBC's "Squawk Box."

"When we see real-world data, will determine if the Omicron is well covered by the third dose and for how long," Bourla added. "And the second point, I think we will need a fourth dose."

On Tuesday, the Pfizer CEO said he was concerned about how fast the Omicron variant is spreading.

"I don’t think it’s good news to have something that spreads fast,” Bourla told the Wall Street Journal. "Spreads fast means it will be in billions of people and another mutation may come. You don’t want that."

Bourla said he expects the number of Omicron cases to balloon from dozens to millions over the next few weeks.

A study in Japan found that the Omicron variant is 4.2 times more transmissible than Delta, Bloomberg reported.

"We will have a good understanding, let’s say before the year end, as to what exactly it means for clinical manifestation," Bourla said.

He said that Pfizer could develop a vaccine that targets Omicron by March 2022, but the pharmaceutical giant is still determining whether the current vaccines provide protection against the newest variant.

Bourla also said, "A third dose will give very good protection, I believe."

BioNTech and Pfizer claimed in a statement Wednesday that three doses of their COVID-19 vaccine were "able to neutralize the new omicron variant in a laboratory test." The press release also said, "Two doses of their vaccine resulted in significantly lower neutralizing antibodies but could still be protective against severe disease."

BioNTech chief medical officer Ozlem Tuereci said two doses of the vaccine "might be compromised," but added, "Three doses of vaccination are required to restore protection."

Dr. Rochelle Walensky — director of the Centers for Disease Control and Prevention — told the Associated Press that "the disease is mild" in almost all of the cases thus far. Reported symptoms mainly were cough, congestion, and fatigue. CDC officials said one person was hospitalized with the Omicron variant, but no deaths have been reported.

"As of Wednesday afternoon, the CDC had recorded 43 cases in 19 states," the AP reported. "Most were young adults. About a third of those patients had traveled internationally."

Walensky said that more than 75% of the patients infected with the Omicron variant had been vaccinated, and a third had received boosters.

The CDC stated, "Current vaccines are expected to protect against severe illness, hospitalizations, and deaths due to infection with the Omicron variant. However, breakthrough infections in people who are fully vaccinated are likely to occur. With other variants, like Delta, vaccines have remained effective at preventing severe illness, hospitalizations, and death."

The Omicron variant — initially known as the B.1.1.529 variant — was first identified in South Africa and was reported to the World Health Organization on Nov. 24.

The WHO said Wednesday that cases of Omicron have been reported in 57 countries. The first documented case of Omicron in the U.S. was detected on Dec. 1.

Bourla said he expects next year to be more normal as long as "a variant that changes everything" doesn't appear.

"I think we were in a good path mid of next year to be having things under control," he stated.