Search and Hit Enter

Serious omissions in Pfizer’s ‘90% effective’ vaccine study

Reports this week that a vaccine for Covid-19 being developed by German pharmaceutical company Pfizer is 90% effective have given rise to relief and rejoicing across the world, with world leaders responding that “the end is now in sight.”

Following close on the heels of Pfizer’s announcement came warnings from public health officials in several countries that a “campaign of misinformation” would likely follow, promoted by anti-vaxxers eager to dampen the public’s enthusiasm in the vaccine. Nonetheless, many of the reservations put forward by experts in the last few days are well-founded and scientifically based, and cannot be easily dismissed.

Speaking at a webinar to the Board of Trustees of the University of Haifa this week, Professor Richard Horton, editor of the prestigious medical journal the Lancet, admitted that “there are question marks surrounding the vaccine.”

He highlighted “the impact on different groups in the population” adding, “and more” before concluding that “we have reason to be optimistic.”

Optimism, in Horton’s book, does not necessarily mean what many people would like to believe. His views have not changed substantially from July, when he granted a lengthy interview to the Washington Post in which he emphasized that “a vaccine is not going to take this virus out of our society.

A vaccine is never 100 percent effective, 100 percent safe, and available to 100 percent of people … I’m pretty sure we’re going to have a vaccine next year, but that isn’t going to mean we’re going to be able to go back to our fully normal lives.”

All the same, 90% efficacy is pretty impressive. By way of comparison, the flu vaccine’s efficacy is estimated at anywhere in the range of 30% to 60%, and has to be administered at least once a year. But what does that 90% actually mean?

Pfizer enrolled 43,538 people in its study, in the so-called Phase 3 stage of its trials. Each volunteer was given either two doses of the vaccine or two salt-water placebo injections. 94 people reportedly contracted Covid-19 during the trial. Based on the data – which was not released along with the announcement – Pfizer declared that the vaccine had been shown to be 90% effective. However, the trial only considered people to have “contracted coronavirus” if they showed symptoms and also tested positive.

Trial volunteers (both in Pfizer’s trial and those conducted by other pharmaceutical companies and research teams) were and are not regularly tested for coronavirus if they fail to exhibit symptoms.

Given what we know about coronavirus by now i.e. the high percentage of carriers who are asymptomatic, this appears to be an astonishing omission.

Of course, in the theoretical case where 100% of the population agrees to be vaccinated, this caveat is less significant, as 90% of people will likely be prevented from developing serious illness as a result, if the data is proven correct. However, given that this is unlikely to happen, the omission is certainly worrying.

True, those vaccinated may be unlikely to die from coronavirus, but they are still perfectly capable of passing it on to unvaccinated individuals who may suffer serious consequences.

In a nutshell, any vaccine that fails to prevent asymptomatic cases as well as more serious ones is simply not going to stop the pandemic.

Pfizer has predicted that it could have over one billion vaccine doses ready by next year. Given that there are around 7 billion people in the world, that’s clearly not enough. Given that governments are already racing to be first in line to receive those shots, it also seems unlikely that a global program to ensure that the available vaccines reach those most vulnerable stands any chance of being implemented, let alone planned and designed. So, unless a country buys enough doses for its entire population and forces everyone to be vaccinated, a future of border controls, “red” countries, and ongoing outbreaks seems the more likely prospect than “defeating this virus.”

Horton has, in the past, expressed his admiration that ongoing vaccine research into Covid-19 “has been a truly global collective effort,” adding that it is “phenomenal to go from discovery of a new virus to candidate vaccines in six months.” Critically, however, he tempered his enthusiasm by warning that, “Vaccine hesitancy is sufficiently high to render community immunity a challenging goal.”

Following Pfizer’s announcement this week, he reiterated these concerns, noting that, “if problems are discovered [with vaccines being developed] there will be very severe damage to public confidence in vaccines, adding to a trend that already exists.” Horton was relating primarily to vaccines being developed by Russia and China, which are being disseminated (for free) even before Phase 3 trials are completed. However, given that long-term side effects to any vaccine will only and obviously become apparent in the long term, his concerns are also applicable to Pfizer’s product.

Aside from the issues of asymptomatic infection and long-term side effects, there are other concerns that have apparently not been addressed by Pfizer, unless they are keeping some of their findings under wraps.

The study does not seem to have categorized the volunteers into age groups; nor do the results differentiate between serious and mild cases of the illness.

Given that we already know that COVID-19 is far more dangerous to the elderly, this, again, appears to be a serious omission.

And given that one of the aims of governments around the world when imposing lockdowns and other restrictions is to prevent health systems from being overwhelmed by COVID-19 patients, it would seem more than relevant for a vaccine trial to note whether “illness” required hospitalization with or without ICU admission, or whether volunteers who became sick merely had a cough and a week-long fever.

One of the findings that was released by Pfizer noted that the vaccine appeared to become effective 28 days after its initial dose, adding that it remained effective a week after the second dose.

Most of us won’t be wanting monthly coronavirus shots so this begs the question – still begging an answer – of how long protection will last.

Will it last for a lifetime, as healthcare experts claim is the case with measles, for instance? Or will it be a matter of mere months, like the flu vaccine? No one knows, and admittedly that’s not Pfizer’s fault. It’s simply impossible to know at this point.

Pfizer’s CEO, Albert Bourla, said in a statement a few days ago that the company would be releasing additional data relating to efficacy and safety “in the coming weeks.” But people aren’t waiting those weeks to proclaim far and wide that “we’ve turned the corner.” In a briefing on Monday, Dr. Anthony Fauci said that Pfizer’s vaccine will “have a major impact on everything that we do with regard to COVID.” He may be right. This vaccine – whether or not it works, whether or not it’s truly safe – may just be the tree governments across the world have been waiting for to climb down from their lockdown perches.

Now it’s up to us to decide if we want to be part of the experiment.

(Let’s just hope we’re given the choice.)

Source: V. Rabinowitz – Arutz Sheva