JERUSALEM – Israel, the world leader in vaccinating its population against the coronavirus, has brought out some encouraging news: Early results show a significant decrease in infection after just one shot of a two-dose vaccine and better than expected results after both doses.
Public health experts warn that the data based on the Pfizer BioNTech vaccine are preliminary and have not been subjected to clinical studies. Nevertheless, Dr. Anat Ekka Zohar, Vice President of Maccabi Health Services, one of the Israeli health maintenance organizations that released the data, called them “very encouraging”.
In the first early report, Clalit, Israel’s largest health fund, compared 200,000 people aged 60 and over who had received a first dose of the vaccine to a corresponding group of 200,000 who had not yet been vaccinated. The partially vaccinated patients were said to be 33 percent less likely to be infected 14 to 18 days after their shots.
Around the same time, Maccabi’s research department said they saw an even greater decrease in infections after just one dose: a decrease of about 60 percent, 13 to 21 days after the first shot, in the first 430,000 people to receive it.
Maccabi did not provide an age group or whether the data were compared to a matching, unvaccinated cohort.
On Monday, the Israeli Ministry of Health and Maccabi released new data on people who received both doses of the vaccine, showing extremely high rates of effectiveness.
The ministry found that of 428,000 Israelis who received their second dose, only 63, or 0.014 percent, contracted the virus a week later. Similarly, the Maccabi data showed that more than a week after receiving the second dose, only 20 out of approximately 128,600 people, about 0.01 percent, had the virus.
In clinical studies, after two doses, the Pfizer vaccine was found to be 95 percent effective in preventing coronavirus infection in people with no evidence of previous infection. The Israeli results suggest that the effectiveness could be even higher, although rigorous comparisons with unvaccinated people have not yet been published.
“This is very encouraging data,” said Dr. Zohar. “We will closely monitor these patients to see if they continue to have mild symptoms and do not develop complications from the virus.”
Both Clalit and Maccabi warned that their results were preliminary and said they would soon be followed by more in-depth statistical analysis in peer-reviewed scientific publications.
Israel, where more than 30 percent of the population has already received a first dose of the vaccine, has become an international test case for the effectiveness of the vaccine.
With its small population, highly digitized universal health system, and rapid adoption of military-backed vaccines, Israel’s real world data provides a useful addition to clinical trials for researchers, pharmaceutical companies, and policy makers.
Israel has signed a contract with Pfizer, under which the pharmaceutical company ensured the country an early and steady supply of vaccines in exchange for data. The Ministry of Health has published an edited version of the agreement.
Despite its race to vaccinate, Israel is suffering from a devastating third wave of the coronavirus. The government put a strict national lockdown this month after weeks of infections and deaths.
Israel should suspend most air travel in and out of the country from midnight on Monday to block the arrival of emerging virus variants that could jeopardize the country’s vaccination campaign. Two vaccine manufacturers said Monday that their vaccines were a little less effective against one of the new variants.
Such real-world data from Israel, while useful, is subject to variables that may skew results and that clinical studies should take into account.
The early Israeli numbers are based on the first people to receive the vaccine. Such people, experts say, are likely to be more concerned or informed about the virus, and therefore more cautious about social distancing and wearing masks. They could also differ from those who did not hurry to determine the location and socio-economic status.
Experts also say that the disease changes over time. Prof. Ran Balicer, Clalit’s chief innovation officer and leading Israeli epidemiologist, said two-week-old dates may be like evidence from another time or “about a million vaccines in Israeli terms”.
Maccabi said it would publish more data every week. “The main message,” Maccabi said in a statement, is that the first dose of the vaccine “is effective, reducing morbidity and hospital stays by tens of percent.”
Experts point out that publishing raw data carries the risk of being misinterpreted.
After Clalit first released its early numbers two weeks ago, many people heard of a 33 percent decrease in cases, not the 95 percent expected, and came to the wrong conclusion that the Pfizer shot wasn’t working.
There has been an uproar in the UK with authorities delaying delivery of the second dose by up to 12 weeks, in contrast to the 21-day hiatus on which Pfizer based its experiments.
Professor Balicer considered the results to be good news and was dismayed by how they were interpreted.
“We were calm enough to tell everyone we see what we should see right after day 14,” he said. “I don’t know how it became a message of ‘Oh my god, it doesn’t work’.”
Professor Balicer, who also chairs the team of experts advising the Israeli government on its response to Covid-19, hoped the positive results could have an impact on an upcoming government decision on a third lockdown.
Answers to your vaccine questions
Am I eligible for the Covid vaccine in my state?
Currently more than 150 million people – almost half of the population – can be vaccinated. But each state makes the final decision on who goes first. The country’s 21 million healthcare workers and three million long-term care residents were the first to qualify. In mid-January, federal officials asked all states to open eligibility to anyone over the age of 65 and adults of any age with medical conditions that are at high risk of becoming seriously ill or dying of Covid-19. Adults in the general population are at the end of the line. If federal and state health authorities can remove bottlenecks in the distribution of vaccines, everyone over the age of 16 is eligible as early as spring or early summer. The vaccine has not been approved in children, although studies are ongoing. It can take months before a vaccine is available to anyone under the age of 16. For the latest information on vaccination guidelines in your area, see your state health website
Is the Vaccine Free?
You shouldn’t have to pay anything out of pocket to get the vaccine, despite being asked for insurance information. If you don’t have insurance, you should still get the vaccine for free. Congress passed law this spring banning insurers from applying cost-sharing such as a co-payment or deductible. It consisted of additional safeguards prohibiting pharmacies, doctors, and hospitals from charging patients, including uninsured patients. Even so, health experts fear that patients will end up in loopholes that make them prone to surprise bills. This could be the case for people who are charged a doctor’s visit fee with their vaccine or for Americans who have certain types of health insurance that are not covered by the new regulations. If you received your vaccine from a doctor’s office or emergency clinic, talk to them about possible hidden costs. To make sure you don’t get a surprise invoice, it is best to get your vaccine at a Department of Health vaccination center or local pharmacy as soon as the shots become more widely available.
Can I choose which vaccine to get?How long does the vaccine last? Do I need another next year?
That is to be determined. It is possible that Covid-19 vaccinations will become an annual event just like the flu vaccination. Or the vaccine may last longer than a year. We’ll have to wait and see how durable the protection from the vaccines is. To determine this, researchers will track down vaccinated people to look for “breakthrough cases” – those people who get Covid-19 despite being vaccinated. This is a sign of a weakening of protection and gives researchers an indication of how long the vaccine will last. They will also monitor the levels of antibodies and T cells in the blood of people who have been vaccinated to see if and when a booster shot might be needed. It is conceivable that people might need boosters every few months, once a year, or just every few years. It’s just a matter of waiting for the data.
Does my employer need vaccinations?
“Covid has turned us all into amateur scientists,” said Talya Miron-Shatz, associate professor and medical decision-making expert at Ono Academic College in central Israel. “We all look at data, but most people aren’t scientists.”
Israel, which began vaccinating people on December 20, has given a first shot to more than 2.6 million Israelis and both shots to more than a million people.
Having started with people aged 60 and over, healthcare workers and other vulnerable people, Israel now offers vaccinations for people over 40 and students aged 16-18 to help them go back to school. The military is supporting the effort and 700 army reserve medical personnel are helping at vaccination centers.
Prof. Jonathan Halevy, the president of Shaare Zedek Medical Center in Jerusalem, had not examined the results of the HMOs, but said he had noticed a decrease in severe cases two weeks after the first dose was introduced.
“I know several people who got infected shortly before the vaccine, but they got it easily,” he said.
Still, Israel remains under a national lockdown and officials are concerned about the emergence of new, highly contagious varieties. It remains to be seen how effective the vaccines will be against the new variants.
Despite the vaccine’s seemingly early success, the virus continues to wreak havoc in Israel. Professor Halevy said his hospital’s Covid wards are still full and he reckons it would take another two or three weeks for a decline to be seen.
The virus has killed more than 1,000 Israelis this month alone, nearly a quarter of those who died from the pandemic virus in total.
Health officials and experts have attributed much of the recent surge in infection to the fast-spreading variant, which was first discovered in the UK.