In the US, and to a large extent also in the UK, there is currently a political battle between those who support the immediate administration of a third dose of vaccine, to the general population or to all adults, and those who offer to wait for more information. Aspects and are looking for a quick solution to the re.emergence of the epidemic, and those who are in charge of maintaining the proper administration of the drug approval field, and consider the FDA, the US Food and Drug Administration, the Holy of Holies. FDA and its decisions, and at stake it is more significant than a quick approval of one product, even at the cost of human life at the moment.
Meanwhile, in Israel, the pragmatic decision has already been made, and it seems to be even bearing fruit. That is why Israel has once again become a test country for the world. “I think the US administration saw that Israel had already approved, and they were pressured,” Jesse Goodman, a former FDA chief scientist, told The Hill political news website.
Tensions between the parties began when US President Joe Biden said he expects to be ready for the start of the third vaccination campaign on September 20 – he has a school year and higher education to save. At the same time, hospitals are collapsing, the US 1,500 deaths a day, mostly in the least vaccinated countries in the first place. Thousands of children across the country are also among those hospitalized.
A two.dose vaccine is not enough to suppress the Delta variant
In recent weeks, articles have begun to appear in the United States that tell the public what we already see and understand in Israel: a two.dose vaccine (at least a Pfizer vaccine given six months or more ago) is better than a non.vaccine, but not enough to suppress Delta variant.
But after Biden’s statement, two senior FDA vaccine division officials announced their retirement surprisingly. They apparently felt that the preliminary statements about the start date of the campaign, created in them a sense that the administration is making decisions without them.
Dr. Janet Woodcock, FDA Chief, and Dr. Rochelle P. Wolansky, head of the CDC (U.S. Centers for Disease Control), both told the White House at a meeting this week that they do not currently have enough information to approve the additional shot, and may not have that information or will not be able to analyze it properly in the coming weeks. It should be noted that Woodcock and Wolensky co.wrote the plan for the booster campaign with the government, and for the seniors in the vaccine division, that was part of the problem – too crowded talk between the regulator and the government.
Biden has branded himself in his election campaign as the president who will listen to scientists and professionals from the FDA. A White House spokesman confirmed following the resignation of senior officials and the media noise created that any decision would be made in consultation with the professional bodies. Initially, Biden said the third vaccine would be given starting Sept. 20 “subject to FDA approval.” But in that speech he had already begun to sell to the public the better future after the impulse shot. “It will protect you and end the plague,” he promised, and now he will have a hard time retreating from it as well.
The data in Israel are on Pfizer vaccines, and the vaccines in the United States are modern
Part of the dilemma stems from the fact that the data on the third vaccine coming from Israel are only regarding the Pfizer vaccine. In the U.S., residents have also been vaccinated with a modern vaccine, which has a higher dose and appears from laboratory trials because its decline may be slower, as well as the Johnson & Johnson vaccine, which is being developed in a different technology and has almost no information about its decline patterns.
The parties may make a compromise decision to add a third vaccine only to those who were initially vaccinated with Pfizer’s vaccine, although it is difficult to see this decision being made in public, as the decision as to who will be vaccinated with what was originally was almost random. Only special risk groups may be allowed to be vaccinated in the third, in addition to those who have already been vaccinated.
The FDA and CDC people also have questions about Pfizer’s vaccines. They claim to have received information about the effectiveness of the vaccine from Israel, but not the raw data that could allow them to process the information themselves. It seems that the PA does not trust one hundred percent of the data that came out of Israel. There is no doubt that a body like the FDA has more experience in analyzing issues of new medical treatment approval than the Israeli Ministry of Health, although the data presented by the Ministry of Health seem to signal very strongly in favor of the booster dose.
On September 17, the FDA’s Immunization Advisory Committee, made up of vaccine experts, is due to review the information provided by Pfizer. On Friday, Modern also submitted its application for impulse vaccine approval, and will soon set a date for a discussion of that approval as well.
But the U.S. general surgeon (roughly equivalent to the head of public health services), Dr. Wiwok Morty, actually supports rapid progress toward a third vaccine. “We are seeing a decline in defense even against a serious illness, and the feeling is that as we wait, we will see a complete disappearance of defense.” Woodcock also edited that this is the direction, and that the vaccine is urgent, but its new position probably stems from the desire to balance public confidence in the process and the acceleration of solutions, and probably from the fact that the existing information is really insufficient.
“Time does not work in our favor”
In the UK, a similar debate took place. The JCVI, an outside body that is supposed to advise the government on vaccines, noted that it is still too early to make decisions about the booster dose. Britain has removed all corona restrictions, and the number of verified, hospitalized and dead has risen. But the JCVI wants to wait for the results of the Covid.Boost trial. This experiment was conducted by the UK National Insurance Fund, the NHS, and is testing seven combinations of vaccines to figure out which combination is most effective.
In the UK the situation is complex because many of the vaccinated have received the injection of astrazene, whose decay dynamics may be different from that of RNA vaccines. Former UK Health Minister Jeremy Hunt has told the BBC that there is no need to wait for the JCVI’s decision to give a third vaccine because “they are in principle in favor, and time is not working in our favor”. He said: “We must emulate the Israeli program. They have more vaccinated than we do, and they did not face the delta, but two weeks after they started vaccinating the boosters, the level of serious morbidity is falling again. I understand why scientists take the time not to make the wrong decision. The government can see where the wind is blowing. “
British Prime Minister Boris Johnson said there would be a vaccination program in September, but also hinted that it would focus on risk groups.
Professor Sir Arnold Pollard, Chairman of the JCVI, replied to Hunt that: “The World Health Organization recommends that all countries have a vaccine advising body that is independent of political influences, and in the UK it is the JCVI. An independent committee is important. It does not depend on political urgency and considerations that last as long as one term, but can make long.term decisions about the safety of our public. We make decisions again as new information arrives. “Because key research is being conducted here in the UK, it is true that JCVI will consider all of this information to provide the best advice based on the data needed for this decision.“
The director of the University of Southampton’s Cov.Boost trial, Professor Sol Faust, said: “It is difficult to understand the timing of politicians (referring to Hunt) in this context. “Data and reach a decision as early as next week. Immediately after receiving the information, there will be a decision, and people can be sure that they are getting the safest and most effective dose.“