COVID19 update, March 13, 2021: interview with Pfizer CEO Albert Bourla on Israeli vaccination drive/”Phase IV clinical field trial”

Dr. Albert Bourla, the CEO of Pfizer, appears here in an interview on Israeli Channel 12 (in Greek-accented[*] English, with Hebrew subtitles). [Hat tip: Mrs. Arbel.]

He actually only got his own 2nd dose days ago, as he did not want to “jump the queue”. In fact, he was scheduled to visit Israel, but apparently was under mixed pressure from anti-Netanyahu Brahmandarins (who wanted to rob Bibi of his victory roll) and pro-Bibi elements who wanted him to come, and appears to have conveniently found “logistical constraints” why he couldn’t come. He says in the interview that he has no desire to engage in politics, especially not of a country he doesn’t live in — although he stressed his love for Israel as a Jew[*] — and that Pfizer will do business with any government agency regardless of who is in power.

He also intimated that Pfizer was eager to have a small country-sized test case, and that Israel was uniquely placed because of its confluence of comparative smallness, dense population, universal healthcare at a high level with digital record keeping (99% of the population is enrolled in one of the four licensed HMOs[**]), and good logistics. He also cites Israel’s general disaster preparedness (which is less than I’d like it to be). But what tipped the scales for him, he says, was the “obsessive” manner in which PM Netanyahu called him something like 30 times, and the detail-oriented manner of his questions — which convinced him “this guy is really on top of things”. (Friend and foe acknowledge Bibi’s intellect.)

A recent press release by Pfizer claims that the vaccine is 97% effective, which exceeded even the results of Pfizer’s clinical trial. I’d have preferred if they had “shown their work”, but I suspect a paper is currently undergoing peer review or being prepared for the same. At any rate, earlier a paper appeared in the New England Journal of Medicine with results for 600,000 vaccinated patients of the Clalit HMO (and a control group of 600,000 unvaccinated ones). As per well-established procedures in medical statistics: in order to eliminate “confounding factors”, the control group was sampled from a (then still) larger group of unvaccinated patients in such a way that it resembles the vaccinated group as closely as possible in terms of age distribution, (sub-)ethnicity, and pre-existing conditions.

The paper is Open Access (not paywalled): Dagan, N.; Barda, N.; Kepten, E.; Miron, O.; Perchik, S.; Katz, M. A.; Hernán, M. A.; Lipsitch, M.; Reis, B.; Balicer, R. D. BNT162b2 MRNA Covid-19 Vaccine in a Nationwide Mass Vaccination Setting. N. Engl. J. Med. 2021, NEJMoa2101765. https://doi.org/10.1056/NEJMoa2101765.
My short summary in table form of the main findings:

Endpoint1st doseboth doses
documented infection46% (40-51)92% (80-95)
symptomatic COVID57% (50-63)94% (87-98)
hospitalization74% (56-86)87% (55-100)
severe disease62% (39-80)92% (75-100)
deathtoo few for mean-ingful statistics
Table 1: Effectiveness relative to control group (95% confidence intervals in parentheses)




Note that the uncertainty intervals grow as the endpoint becomes more severe, as you are increasingly doing “statistics of small numbers” in the vaccine arm. Indeed, those for hospitalization and severe disease encompass 100%! The lead author on the paper is the head of the research division of Clalit (“General”, the largest of our four HMOs). Unpublished figures I’ve seen from competitor Maccabi are even better: presumably, because of a data-sharing agreement with Pfizer, the latter’s study will be aggregated from data of Clalit, Maccabi, Meuchedet (“United”), and niche player Leumit (“Nationalist”, which used to have a quasi-monopoly in the disputed territories).

What does “90% effective”, say, mean in such a trial? It means that, in equal and comparable “vaccinated” and “control” groups, the number of vaccinated people who got infected is one-tenth of the number in the control group who got infected.

Current statistics are available online at the Ministry of Health’s COVID dashboard to anyone who can read a little Hebrew. Let me give a few highlights of what we’re seeing now, despite exit from lockdown:

  • hospitalized severe cases are down from a peak of about 1,200 in mid-January to about 600, comparable to late December
  • daily verified infection have dropped from about 10,000 to about 3,000
  • the percentage of positive tests is at about 3%, compared to a maximum of 16% last September
  • the propagation coefficient R is down to 0.83 in spite of nearly-full unlock
  • out of a population of 9 million of which a bit of 6 million is eligible (the rest being either our 27% children under 16 or the 0.75 million who have recovered from previous COVID), 4.1 million have had both jabs and another million has had the first jab and is in its 3-week wait for the second

From Prof. Eran Segal’s twitter feed, this update:

Image

Israel kind-of has its own built-in control experiment. Allow me to explain. There are three major sectors (Hebrew: migzarim) in the population, largely self-segregated: the chareidi (“ultra-Orthodox”) sector, the Arab sector, and the “general sector” of everybody else (secular, traditional, Orthodox, and non-Jews who are not Arab). According to an internal report I was privy to, unvaccinated eligible people are currently below 10% in the general sector. (Uneligible are people under 16, and people who have had a documented COVID infection in the past, regardless of religion or ethnicity. Foreign workers were recently made eligible, although live-in caregivers had been informally vaccinated from the start, at the same time as their patients.)

In the chareidi sector, both the percentages of children under 16 and unvaccinated eligible adults are higher, but this is compensated in part by the unusually high level (20%) of people who got the disease and recovered (four times the 5% or so figure in the general and Arab sectors). As we know there is a Dunkelziffer of undocumented infections, the percentage of chareidim with some level of post-infection immunity may well be 40 or even 60%?

In the Arab sector, however, there has been the greatest reluctance to get vaccinated. According to an internal report I have seen, not only has morbidity continued to rise in the Arab sector, but Arabs now account for almost half of hospital admission with severe COVID (about 3x what is expected from their share in the population). Had it been a matter of “oh, this is going over on its own, the vaccines have nothing to do with it”, we would not have seen this in the Arab sector.

ADDENDUM: I forgot to mention the subject of a “booster shot” for mutations. Dr. Bourla says a trial is in progress for the South African and Brazilian mutations; the internal goal he said is 100 days from identification os a mutation of concern to production of a booster for the strain. The British mutation is a nonissue here, since the Israeli results (where 80% of the viral population was British mutation, meanwhile over 90%) clearly show the current vaccine is equally effective as for the original wild-type (“classic COVID”, pardon the macabre humor).

[*] Bourla was born in Thessaloniki, Greece’s 2nd city, to a family of Sephardic Jews. During the Ottoman Empire (of which Thessaloniki was the largest port), the city had the largest Jewish population of any city in the world.

[**] A large chunk of the remaining 1% is accounted for by the IDF, which of course has its own Medical Corps.

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