BioNTech and Pfizer said on Wednesday a three-shot course of their COVID-19 vaccine was able to neutralize the new Omicron variant in a laboratory test and they could deliver an upgraded vaccine in March 2022 if needed.

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The German and US companies said two doses of their vaccine resulted in significantly lower neutralizing antibodies but a third dose boosted those antibodies by a factor of 25.

"The first line of defense, with two doses of vaccination, might be compromised and three doses of vaccination are required to restore protection," BioNTech Chief Medical Officer Ozlem Tuereci said at a press conference. The companies suggested that two doses may still protect against severe disease.

BioNTech and Pfizer are the first manufacturers of a COVID vaccine to issue an official update on the efficacy of their shot against Omicron.

In samples of blood taken around a month after the third shot, the Omicron variant was neutralized about as effectively as two doses neutralized the original virus identified in China.

BioNTech CEO Ugur Sahin suggested that countries might consider shortening the time period between second and third doses of the vaccine to combat the new variant.

He cited recent moves by countries including Britain to bring the third shot forward to three months after the second shot, from six months previously.

"We believe this is the right way to go particularly if the Omicron is now spreading further, to enable a better level of protection in the winter season," Sahin said.

The Omicron variant, first detected in southern Africa and Hong Kong last month, has triggered global alarm about another surge in infections. Cases have already been reported from Japan to the United States and across Europe.

The World Health Organization classified Omicron on Nov. 26 as a "variant of concern" but said there was no evidence to support the need for new vaccines specifically designed to tackle the variant and its mutations.

Nevertheless, the companies said they would continue efforts to bring an Omicron-specified COVID-19 vaccine to market. Work started when the variant first raised concern on Nov. 25.

They said their planned production of four billion doses of the Comirnaty vaccine in 2022 was not expected to change if an adapted vaccine was required.

The findings are broadly in line with a preliminary study published by researchers at the Africa Health Research Institute in South Africa on Tuesday, which said Omicron could partially evade protection from two doses of the Pfizer/BioNTech vaccine and suggested a third shot might help fend off infection.

Research on the new variant is still at an early stage. Laboratory analysis at University Hospital Frankfurt in Germany found the ability to mount an antibody response to Omicron in people who had three shots was up to 37 times lower than the response to Delta.

"The companies believe that vaccinated individuals may still be protected against severe forms of the disease," BioNTech and Pfizer said.

The vast majority of surface structures on the Omicron spike protein targeted by the T-cells, which typically emerge after vaccination, are not affected by Omicron's mutations, they said.

T-cells are the second pillar of an immune response, alongside antibodies, and are believed to prevent severe disease by attacking infected human cells.

For their analysis, the two companies used a virus that was bio-engineered to have the hallmark mutations of Omicron, known as a pseudovirus, and blood was collected from subjects three weeks after a second vaccine dose or one month after a third.

There is no significant data yet on how vaccines from Moderna, Johnson & Johnson, and other drugmakers hold up against the new variant but they are expected to release their own data within weeks.

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Israel is set to begin vaccinating teenagers aged 12 to 15 against the coronavirus on June 6, the Health Ministry announced, Sunday.

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Despite the announcement, Health Ministry Director-General Hezi Levi has yet to consolidate a decision as to the safety of the vaccine in children. The assessment is that there are around 600,000 children in this age group in Israel.

In a meeting, Sunday, Health Ministry representatives informed healthcare providers that in the first stage, vaccinations would be performed in schools, providing maximum access to youths from all sectors.

Magen David Adom emergency services, which assisted healthcare providers earlier on in the vaccination campaign, is expected to be tasked with vaccinating students. Later on, healthcare providers will be informed which of their members in this age group have yet to be inoculated and will take over the campaign.

Following in the US Food and Drug Administration's footsteps, the European Medicines Agency approved the emergency use of Pfizer's vaccine in teens aged 12 to 15 over the weekend.

The Health Ministry is waiting on its team of pandemic experts to decide on the vaccination of teens.

The Health Ministry has been collecting data on teens who experienced heart inflammation within one week of receiving Pfizer-BIONtech's coronavirus vaccine. Around 70 cases have been reported in Israel thus far.

Myocarditis, an inflammation of the heart muscle, often goes away without complications and can be caused by a variety of viruses.

The ministry is comparing the prevalence of complaints of heart inflammation following inoculation to recent years as well as comparing instances of heart inflammation among vaccinated and unvaccinated teens.

As most cases of heart inflammation were reported upon receiving a second dose of the vaccine, one of the options on the table would see teens receive one dose instead of the accepted two doses of the vaccine.

Levi said: "We are being attacked for holding off on a decision and being cautious. We're holding talks and collecting material. As for reports of heart inflammation, we are being cautious in our examination of all the instances, seeing whether there is a connection between the events and the vaccines. We are going over all of the medical files and checking everything."

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The mRNA COVID-19 vaccine may have reduced efficacy in individuals with two types of blood cancer, chronic lymphocytic leukemia (CLL) and multiple myeloma, a new study from a team at Sourasky Medical Center in Tel Aviv published in the hematology journal Blood suggests.

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The first study, under lead author Dr. Yair Herishanu, associate professor in hematology and head of the CLL service at Sourasky, reports that people with CLL had markedly lower immune response rates to the two-dose mRNA COVID-19 vaccine than healthy individuals of the same age.

Because clinical trials of these vaccines did not include patients with blood cancers, who are at high risk of severe illness and complications from the virus, gauging the effectiveness of the vaccine in this population is critically important.

The study was conducted from December 2020 to February 2021 on 167 patients with CLL and 53 healthy controls. All participants received two doses of BNT162b2 messenger RNA (Pfizer) COVID-19 vaccine 21 days apart; this was the only vaccine used in Israel at the time of the study. Patients were 71 years old on average, and 67% were men. Fifty-eight patients (34.7%) were treatment naïve; 75 (44.9%) were on active therapy; 24 (14.4%) were previously treated and in complete or partial remission; and 10 (6%) were in relapse.

Only four out of 10 (39.5%) of the participants in the study had a positive antibody-mediated response to the vaccine; all healthy adults (controls), by comparison, marshalled an immune response.

Antibody titers (an indication of the intensity of the body's response to the vaccine) were also measured two weeks after the second dose. Patients were followed for a median of 75 days since receiving their first shot, and none had developed COVID-19 infection. There were no significant differences in reported side effects to the vaccine compared to the healthy population.

Interestingly, the research revealed wide variations in immune response among patients with CLL, depending on where they were in their cancer treatment process. Patients undergoing active cancer treatment had significantly lower response rates to the vaccine when compared with people who had completed treatment and were in remission, 16% vs. 79%, respectively. Treatment naïve patients (those whose disease is being watched but not yet treated) had a 55.5% response rate. As well, response to the vaccine was markedly higher in people who completed CLL treatment at least a year before vaccination compared with those who were still in treatment within the last year, 94% vs 50%, respectively.

"Overall, the response rate to the vaccine was significantly less than what we see in the general population, which is most likely attributed to the presence of cancer itself and certain CLL treatments," Herishanu explained.

In addition to poorer qualitative antibody responses to the vaccine, patients with CLL also had lower antibody titers, which tells us that, in addition to fewer patients responding to the vaccine, the intensity of their response was also lower, explained Herishanu.

"It would seem that if you are untreated, in what we call 'watch and wait' or do not have active disease, you can gain more benefit from the vaccine. Patients who responded the best were in remission, which makes sense because their immune system had a chance to recover," Herishanu added.

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The Sourasky study also indicated that aside from not being on active CLL treatment at the time of vaccination, younger age, being female, and normal immunoglobin levels at the time of vaccination independently predicted better response rates to the vaccine.

Researchers also looked at immune response to the vaccine based on which CLL treatment patients received. They found similarly low response rates among patients who were receiving common targeted therapies, including Bruton's tyrosine kinase (BTK) inhibitors (ibrutinib or acalabrutinib) or a combination of venetoclax with anti-CD20 antibodies such as rituximab. Notably, none of the patients who received anti-CD20 antibodies within 12 months of COVID-19 vaccination responded. Because only five patients were on venetoclax monotherapy, Herishanu said they could not draw any conclusions about the impact on response.

People with CLL and other blood cancers remain at high risk for severe illness and complications with COVID-19 infection, and while response rates are lower than ideal, vaccination against COVID-19 is strongly recommended. The authors suggest that an additional booster dose of the vaccine might be needed for patients with CLL who have completed therapy and previously failed to respond to COVID-19 vaccine, though this would need to be studied.

"Even though response rates were not optimal, patients with CLL should still get the vaccine and, if appropriate, it may be better to do so before CLL treatment starts although the disease itself may affect the response," said Herishanu. "Equally important is continuing to take precautions – wearing a mask, avoiding crowds, keeping a social distance, and being sure close contacts get vaccinated against COVID-19."

Herishanu and his team will continue to follow these patients for 12 months to see how many, if any, develop COVID-19 infection following vaccination. Since this study only assessed antibody response, they also plan to check the cellular immune response to gain a more complete picture of the extent to which patients are protected after vaccination.

The researchers noted that the same trends would be expected with the other mRNA vaccine (produced by Moderna).

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