After the FDA (US Food and Drug Administration) advisory committee decided yesterday (Friday) not to recommend giving the third vaccine to 16-year-olds in the U.S., that is, to the majority of the population, many in Israel tried to understand the implications of the decision.
To this end, we at "Israel Today" took some of the most common questions that have arisen since the decision, and gave them a broad answer to explain the meaning of the decision.
What has the FDA advisory committee decided on vaccines?
During a nearly eight-hour night-long hearing, the committee discussed Pfizer's request for permission to use the third-dose vaccine for 16-year-olds and older.
The committee decided not to recommend giving the booster vaccine to this age group, not because its members felt the vaccines were unsafe, but because of a lack of information on their need and benefit for a young population less prone to serious illness.
The Advisory Committee is an advisory body to the FDA.
Its recommendations are very important and influential, but the US Food and Drug Administration is not committed to them.
In addition, the committee is expected to continue discussing the issue of booster vaccines in the future, so it is possible that in light of other data to be obtained in the future, the decision will change.
A young man receives the third vaccine against Corona in Tel Aviv, last week // Photo: Gideon Markovich, Gideon Markovich
Does the decision mean the booster is unsafe for those 65 and under? (Or: I am 40 years old and vaccinated with a booster, do I have cause for concern?)
As mentioned, the decision was made because there was not enough evidence regarding the need for such a vaccine and its benefit to a young population.
The data in Israel indicate that the effectiveness of the vaccine is declining even among those aged 40 to 60. In addition, monitoring of side effects from Israel shows that so far all reports of mild side effects after the third dose have been lower than those reported in the first two doses.
In addition, a study by Clalit Health Fund was recently published in Israel, which shows that the risk of a young population developing myocarditis due to coronary heart disease is 3.5 times greater than the risk of developing this infection as a result of the vaccine.
The vaccine also significantly increases the risk of protecting vaccinators from long-term effects of corona ("Long Cubid").
A boy gets vaccinated against Corona, in Be'er Sheva // Photo: Dudu Greenspan, Dudu Greenspan
Does the decision change the vaccination campaign in Israel?
Israel's policy to launch a third-dose vaccination campaign was adopted even before receiving an emergency permit and a recommendation from other authorities, including the FDA.
However, there is no doubt that in light of the debate, greater hesitation is expected from the young public, who are still not flocking en masse to come and get vaccinated in the third dose.
There are almost two million Israelis who are entitled to be vaccinated with a booster and have not yet received it.
Will the decision affect the policy of the green mark in Israel?
The Ministry of Health has announced that the new green label will take effect as planned, on October 1.
However, Economy Minister Orna Barbibai said there would be a discussion in the Cabinet of Ministers following the US committee decision.
From October 1, a new green label will take effect in Israel, which will only be given to those aged 12 and over who are vaccinated in three doses (or it is a "fresh" vaccine that has not yet passed five months since receiving its second dose) and recovering.
The recommendation of the Advisory Committee constitutes a "yellow card" for Israel's current policy, and this is expected to lead to petitions being submitted to the High Court on the subject.
People wait in line to get vaccinated against Korona, in Tel Aviv, last week // Photo: Yehoshua Yosef, Yehoshua Yosef
Was Israel's decision too hasty?
Decisions in the State of Israel were made gradually.
Just as the Americans now recommend that those aged 65 and over and chronic patients be vaccinated with a booster, so in Israel they first recommended those aged 60 and over, and later gradually lowered the age as more information on the effectiveness of the booster was accumulated.
As the head of the public health services at the Ministry of Health, Dr. Sharon Elrai-Price, pointed out to the American Committee of Experts, at high morbidity levels, the risk of infection and serious illness also increases among young people.
What information did the FDA have?
In front of the members of the committee was Pfizer's study on the safety of the booster vaccine, which was conducted on 329 people aged 18 to 55, as well as data from Israel that refer mainly to people aged 60 and over, and to a lesser extent to people aged 40 to 60. The third dose of vaccine for those aged 16 and over was ambitious and even excessive, and if they had reduced the age group, they might have received approval.
Footballer Rami Gershon receives the third vaccine dose // Photo: Courtesy of Maccabi Haifa, Courtesy of Maccabi Haifa