More than 1.3 million Israelis have already received both doses of Pfizer-BioNTech’s Covid-19 vaccine.
The extraordinarily rapid and organized vaccination campaign in Israel is unmatched per capita anywhere in the world.
By design, this rapid implementation is providing Pfizer – and the rest of us – with the first essential real-world data on brand new mRNA vaccines.
This type of vaccine instructs cells to produce a “peak” protein that activates the immune system to produce antibodies against the corresponding peak protein on the surface of the SARS-CoV-2 coronavirus, which causes Covid-19.
“Pfizer knows that the data they will get from Israel is good and accurate. They see that our vaccination rate is very efficient so they can report post-marketing data to the FDA quickly, ”says microbiology expert Dr. Natan Keller, vice president of the Institutional Review Committee at Sheba Medical Center and former president of the Israeli Society of Infectious Diseases.
The FDA’s approval for emergency use for the Pfizer vaccine was based on a study of 24,000 vaccine recipients and 24,000 placebo recipients, says Keller.
Israel now has data on more than 2.7 million who have received at least one dose and the number is increasing by about 100,000 per day.
ISRAEL21c gathered information from local experts and national health maintenance organizations (HMOs) about what Israel has learned about the vaccine and its efficient distribution.
We will continue to keep it updated as new data becomes available and as the Modern mRNA vaccine comes into use in Israel.
EFFECTIVENESS OF THE VACCINE
What we know
Pfizer-BioNTech studies have shown that mRNA vaccines are about 95% effective within a certain period of time after the second dose.
“We know that Pfizer’s data was very accurate,” says Keller. “The effectiveness is in the 90s after the second dose – Pfizer says eight days, but I recommend 14 days for full immunity.”
Studies by HMOs Clalit and Maccabi support Keller’s recommendation. Even so, Maccabi saw a 60% drop in hospitalizations for Covid-19 among members aged 60 and over in just two days after the second dose.
“Based on our data, we know that most people infected after the first dose were infected within the first two weeks of vaccination,” says Keller. “We also know that, statistically, the disease is less severe in those vaccinated [even one dose] than in unvaccinated ones. “
In fact, Maccabi reported that while 20 members were infected with Covid-19 after the second dose – out of a total of 128,600 – they experienced only mild symptoms and recovered at home.
Also encouraging was a study by Sheba that found that employees who received both doses had more antibodies against the new coronavirus than patients recovered from Covid-19.
What we don’t know
“For now, no one knows how long the vaccine protects,” says Keller. “We may need updated vaccines every year or two.”
Dr. Gili Regev-Yochay, director of the Sheba Infectious Disease Epidemiology Unit, and her team will be monitoring for more than a year with vaccinated volunteers to continue studying the interaction between the virus and the vaccine.
Regev-Yochay said that vaccinated people are unlikely to still be able to spread the SARS-CoV-2 virus to others, but that has not yet been proven.
Clinical immunologist and microbiologist at Tel Aviv University Ella Sklan. Photo courtesy of Ella Sklan
There is also no scientific data to support the decision of some countries to postpone the administration of the second dose due to the high morbidity and shortage of vaccines.
“Waiting longer can be better, equal or worse,” says Ella Sklan, PhD, from the department of clinical immunology and microbiology at the medical school at Tel Aviv University.
“Since 21 days between doses in the Pfizer tests and 28 days in the Moderna tests were the only conditions tested and proven to be effective, any deviation from these schedules is an experiment,” Sklan told ISRAEL21c.
“This is why most health agencies do not recommend postponing the second dose. However, for other vaccines, although with different mechanisms of action, you can give the second dose half a year later and they work well. “
SIDE EFFECTS
“Israel’s public health system has special software developed years ago for very efficient vaccination logistics and tracking side effects,” said Keller.
“In general, the side effects of the vaccine are extremely rare. With the Covid vaccine, most people have reported minor side effects from the first dose when they come for the second dose, ”he says.
These effects are mainly swelling or pain at the injection site in the arm, which goes on about a day later.
“These comprehensive data are from the medical team or people over 60, so we know most of the real side effects and it looks pretty safe, including minor side effects,” concludes Keller.
VACCINE VS. MUTATIONS
“At the moment, the virus has infected almost 100 million people worldwide, and that creates many chances for the appearance of mutations,” says Sklan.
However, she adds, “we see only one or two mutations in the SARS-CoV-2 virus genome per month – which is not much compared to other viruses. Most mutations do not cause any recognizable changes to the virus and some do harm the virus. It is rare for a mutation to give an advantage to a virus. “
She and Keller agree with experts who assume that existing vaccines will be effective against most new variants.
“MRNA vaccines [from Pfizer and Moderna] they contain the sequence that encodes the spike protein – a large protein composed of 1,273 amino acids in a three-dimensional structure ”, explains Sklan.
“The antibody response generated by the vaccine is against several areas in the peak protein. Thus, if there are mutations, for example in 10 amino acids, we assume that this will have some impact on effectiveness, but it will not completely block the ability of antibodies to neutralize the virus. Furthermore, in addition to antibodies, we have other immunological components that can also attack the virus. “
HERD IMUNITY
Achieving collective immunity – indirect protection that occurs when a sufficient percentage of the population has immunity – depends on the number of infections in a community and other factors, says Sklan.
“But it will be difficult to stop infections if a large proportion of the population, such as children, is not vaccinated,” she adds.
The Pfizer vaccine is approved for people over 16; Israel started vaccinating 16 to 18 year olds. The pharmaceutical company is now testing young people aged 12 to 16. The Israeli government may be the first country to consider vaccinating children under 16 who are at high risk of becoming infected. For the time being, says Sklan, no vaccine developer is testing on children under 12.
“The only thing we can do, until the vaccine is approved for younger age groups, is to vaccinate as many people as possible in the age group who can get it, because that will decrease the number of infections in the general population , the number of critically ill patients with Covid-19 and the likelihood of new variants appearing. “
The Israeli Ministry of Health is now advising pregnant women to be vaccinated, citing several serious cases of Covid-19 in pregnant women and “no evidence of harm resulting from vaccination throughout pregnancy”.
Dr. Ran Balicer, epidemiologist and director of innovation at Clalit Health Services and consultant to the World Health Organization, recently tweeted, “If we can reach 60% [vaccination] In March, viral transmission is likely to be severely disrupted and the dynamics of transmission considerably altered for the better. “
VACCINATION LOGISTICS
SYN-RG-Ai Integrative Solutions used its crisis management experience to help Israeli government agencies deliver fast and efficient distribution of Covid’s vaccines.
Avi Cohen, co-founder of SYN-RG-Ai. Avshalom Levi’s photo for SYN-RG-Ai
“Israel’s vaccination campaign was so successful because the Israeli government used the day-to-day apparatus of our HMO system that reaches all citizens,” said Col. (retired) Avi Cohen, co-founder of SYN-RG-Ai .
“Good logistics will not help if people do not come,” he says to ISRAEL21c. “In Israel, there are few who do not want to get the vaccine, compared to 40% in some European countries.”
Complete research and clinical data from Pfizer and Moderna were provided to primary care physicians at HMOs. These doctors were the first to be vaccinated as an example for their patients.
The logistics were adjusted for each location. For example, in cities with inadequate transportation options, minibuses were available to take people to the nearest city for vaccination.
SYN-RG-Ai is advising several foreign governments and hopes to take the Israeli model to other major cities, states and nations.
Cohen advises all countries to place vaccination logistics in the hands of trusted organizations that work closely with citizens on a daily basis, such as groups of community volunteers.
“If you operate through the strongest and most trusted group in each area, it works,” says Cohen.
LOOKING FORWARD
Even with the arrival of more data on the effectiveness of Covid-19 vaccines, Sheba’s Keller says that preventive measures for masks, social distance and hand washing remain essential.
“As always, there are some people who will not be vaccinated – or who cannot be vaccinated for medical reasons, including under the age of 16, or on chemotherapy, or with immune deficiency – it is very important not to stop taking precautions for many months,” he says. “We have a responsibility to protect them too.”
Balal from Clalit added that precautions are also necessary because no Covid-19 vaccine is 100 percent effective. “There is no complete protection,” he said.