corbella: are we being treated like guinea pigs?

will the unscientific decision by a federal government agency that is turning canadians into human guinea pigs be changed now that the amount of vaccine coming into the country has been increased and accelerated?on tuesday, prime minister justin trudeau announced that pfizer will “move up” five million doses of its pfizer-biontech vaccine from later in the summer into june. that will boost canada’s total expected doses from 4.6 million to 9.6 million for that month alone.coupled with the 1.5 million additional doses of the increasingly controversial astrazeneca vaccine that canada received this week from the u.s., the unscientific decision to allow a four-month spread between first and second shots should be narrowed by the agency that made that decision.cole pinnow, the ceo of pfizer canada, says the decision by canada’s national advisory committee on immunization (naci) to allow a 16-week spread between first and second doses — rather than a recommended three-week spread — is not based on science.“we’re firmly in the camp that we should be following the product monograph or the dosing schedule that health canada approved our product at,” pinnow said during a recent telephone interview.“all the clinical data that we generated, all the science that has established the expectations for the efficiency and effectiveness of our products is rooted in science, and the science supports a 21-day dosing schedule for our product — plus or minus a little bit of a variance, i think (it) is as little as 19 days and up to 42 days,” said pinnow. but certainly not the 112 days that four months represents.“i appreciate that there is some anecdotal, real-world evidence that’s coming in but that data does not support a four-month dosing schedule,” said pinnow. “so we’re disappointed that canada has chosen to differ from the vast majority of the world that is adhering to the 21-day dose schedule, but we also recognize that legally it’s their decision to make.”canada’s chief science adviser, dr. mona nemer, recently said studies have shown that extending the interval between covid-19 vaccine doses has had a negative effect on their efficacy, particularly in seniors.“i’m not aware of data showing that there is efficacy beyond two months of the first dose,” she said. “in the past few weeks, we’ve seen different studies come out showing that the response to the first dose of the vaccine in the people who are elderly, in the people who are immunocompromised, is actually not that good and it wanes quite rapidly,” she said in an interview on ctv.

on march 17, preliminary research out of the u.k. indicated that 95 per cent of cancer patients produced an antibody response if they received the second dose of the pfizer vaccine three weeks after their first, while only 43 per cent of patients showed the same responses if they waited five weeks between doses.“in contrast to its very high performance in healthy controls (more than 90 per cent efficacious), immune efficacy of a single inoculum in solid cancer patients was strikingly low (below 40 per cent) and very low in haematological (blood) cancer patients (below 15 per cent). of note, efficacy in solid cancer patients was greatly and rapidly increased by boosting at 21 days (95 per cent within two weeks of boost),” says the u.k. study.what’s more, the study concludes that not only does delaying the booster shot potentially leave most cancer patients “wholly or partially unprotected, with implications for their own health,” but could lead to the “evolution of voc (variants of concern) strains.”so, this decision by naci could actually help create more dangerous variants of the virus. of course, we all want to speed up the number of canadians who are vaccinated but this unscientific approach could end up harming us more in the end.health canada authorized the vaccines with a 21-day interval between doses of the pfizer vaccine, 28 days between doses of the moderna vaccine, and up to 12 weeks between doses of astrazeneca, not four months.alberta’s chief medical officer of health, dr. deena hinshaw, said thursday that she’s familiar with the u.k. research, which looked at antibody levels primarily in cancer patients.“we have really good real-world evidence on the effectiveness of the vaccine preventing infection, hospitalizations and deaths in older people,” said hinshaw.“in the u.k. and in quebec where they had a longer interval between first and second doses and they were able to watch the impact of that first dose of pfizer on people who lived in long-term care facilities, on people over the age of 80, what they actually saw is that the antibodies don’t tell the whole story and that the protection against infection, against death, against hospitalization was very high even in those older people,” she said.“again, we’ll be looking very closely at the recommendations of (naci) to understand if there are certain groups for whom we may want to have a shorter interval but, again, i want to emphasize that an individual is protected not only by the dose that they receive but by the doses that the people around them receive,” said hinshaw.

however, echoing what nemer has said, pinnow says as far as he knows there is no data that’s gone beyond a two-month interval to demonstrate the effectiveness of the vaccine.“as i understand it, naci has basically forecasted out to four months what they believe will happen. but again, we really feel that decision should be rooted in science not in forecast,” added pinnow.paul lucas, the former president and ceo of glaxosmithkline canada, who retired in 2012, is less constrained in his comments.“(naci) is treating canadians like guinea pigs,” he said in a recent telephone interview. “i’m worried because i’m a science guy, and canada’s coming out and saying we’re not going to give you the vaccine according to the approved label, which is every three to four weeks — not 16 weeks.“there is absolutely no science to support that — dr. (anthony) fauci in the u.s. has been critical of that and canada’s top scientist, appointed by the federal liberal government (nemer), disagrees with that because there’s no science to support it. so, here in canada, we’re really in one big scientific experiment,” said lucas.the naci said it came to the decision to extend the intervals after considering evidence from scientific research and “real-world effectiveness” that shows high levels of protection following a single dose.i’d certainly be willing to delay receiving my first vaccine shot to ensure a more vulnerable person gets their second shot in a more timely way. my guess is many other canadians would, too.licia corbella is a postmedia columnist in calgary. lcorbella@postmedia.comtwitter:@liciacorbella