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opinion: is the pfizer news the end of the beginning?
dr. harry rakowski: a weary world is praying this is the end of our covid-19 fight. how excited should we be?
nov 13 2020
4 minute read
sir winston churchill at the quebec conference in 1943.
national archives of canada
in 1942, winston churchill delivered a famous speech when british troops defeated rommel’s forces at alamein, a much needed victory that marked a key turning point in the ultimate defeat of germany.
he said, ”now this is not the end. it is not even the beginning of the end. but it is, perhaps, the end of the beginning.” there were three more years of war and hardship before ultimate victory came, but this battle showed a weary people that the war could, and would, be won. we hope our war with covid-19 can end much sooner.
with the positive results of the pfizer/biontech se vaccine, a weary world prays that this represents the end of the beginning of our fight against covid-19. the news led to a surge in stock market valuations especially for stocks beaten down by the pandemic. how excited should we be?
what we do and don’t know
the vaccine is completing phase 3 trials in a large randomized group of volunteers, large enough to detect more frequently occurring major side effects and complications. to date, it appears relatively safe with many getting the benign and usual mild flu-like symptoms associated with many vaccines.
it also appears to be effective in preventing infection in most vaccine recipients. this result was hastened by the surge of infected people in the countries where the studies were carried out. thus, a major reduction in spontaneous covid-19 infection in the treatment versus control group was documented earlier than expected. this proves vaccine efficacy in the group vaccinated.
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what we don’t yet know remains critically important.
the data released has come from the company rather from a peer reviewed analysis of the results. much remains to be learned that is key to understanding the true wide scale benefit. what was the rate of positive antibody development? were enough people in different age, racial and risk groups studied to confirm that all will benefit equally? was vital t-cell immunity created and at what rate? how long will relative immunity last without the need for an additional booster dose? will that booster dose be enough and for how long? what additional complications of vaccination will be discovered with larger scale administration and longer surveillance? is this vaccine more or less effective than the other leading candidates who are close behind? how will we overcome the distribution barrier of the vaccine needing ultra cold refrigeration for its storage?
the next steps
first, the pfizer vaccine trials need rapid peer reviewed publication that confirms the degree of benefit and excludes possible trial study flaws.
second, there seems to have been rolling submission of study data for facilitated regulatory approval. the fda appears to be reviewing trial data as it is received, and on an expedited basis. hopefully, health canada has done the same — we need to hear confirmation of this, and if not, a good explanation as to why. in the u.s., this should lead to a limited emergency use approval in december or january.
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we also need confirmation of how many doses have been prepared in advance of approval, as well as the rate of possible ramped up vaccine production. although vice president mike pence tweeted that the u.s. government’s operation warp speed program helped accelerate the development of the vaccine, $445 million from the german government to move the vaccine forward and increase manufacturing capacity.
huge news: thanks to the public-private partnership forged by president @realdonaldtrump, @pfizer announced its coronavirus vaccine trial is effective, preventing infection in 90% of its volunteers.
— mike pence (@mike_pence) november 9, 2020
transparency about which countries have binding agreements to be first in line for the limited production supply is also important. where does canada stand, and when are we likely to get enough vaccine to not only immunize health care workers and our most vulnerable populations, but also vaccinate the number of people needed to get relative herd immunity.
the path to true victory
canada needs to disclose granular details of arrangements with all vaccine producers and our plan for procurement and distribution. also, health canada plays an important role, needing to be much more nimble and efficient in the speed of approval for safe vaccine use. the same should apply for antibody therapy approval. we also need to endure appropriate restrictions until our risks decrease. the second wave is magnified by irresponsible behaviour. and finally, individuals and businesses should be adequately supported so they can survive the economic hardships imposed by restrictions.
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is this the beginning of the end?
we should view the current good news not as the end, or the beginning of the end, but rather the end of the beginning. for now, we must remain vigilant and focused on known beneficial, albeit painful containment strategies. we need to push our governments to be honest and open about our timetable for vaccine procurement. a carefully thought out plan for the prioritization of who gets limited vaccine based on the level of need and benefit is necessary, as is overcoming vaccine hesitancy with good data about safety and effective communication from our government’s health experts.
hopefully, more good news about the success of other vaccines and their availability will soon follow. made in canada vaccines are not too far behind. medicago studies are progressing well but it is too early to tell if their results will be as good as the current leaders. symvivo has enrolled its first volunteer in australia as canadian approval to start trials in canada was unfortunately delayed. the symvivo vaccine provides hope for an inexpensive and easy to deliver oral vaccine that could meet both canadian and the developing world’s need by the fall of 2021.
the welcome news about the pfizer vaccine results truly marks the end of the beginning. let’s hope that in early 2021 there will be enough good news that we can also mark the beginning of the end.
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stay safe, vigilant and optimistic.
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