Eugene Consulting Inc.
1602- 111 St. Clair Ave W
Toronto, ON
M4V 1N5

April/May 2021 Report
COVID Vaccine Updates
Interchangeability of Vaccines• The National Advisory Committee on Immunization (NACI) has provided newrecommendations on vaccine interchangeability saying that COVID-19 vaccines types
should remain consistent• They have however stated that if a second dose of the Oxford-AstraZeneca vaccine isunavailable, it could be supplemented with the single-dose Johnson and Jonson’s Janssenvaccine• There is currently no data on the interchangeability of COVID-19 mRNA vaccines although
the committee states there is no reason to believe that mRNA vaccine series completion
with a different authorized mRNA vaccine product would result in any additional safetyissues or de iciency in protection• In Ontario, public health of icials have announced that they will offer the province’s
remaining inventory of AstraZeneca COVID-19 vaccine to those awaiting their second
dose of the shot, however, they will not offer AstraZeneca shots to anyone else as a irst
dose
• Preliminary results from a study in the U.K. suggest that interchanging vaccines is safe,
however, could be more likely to lead to mild side-effects such as a headache, chills, or afever• The study looked at more than 800 adults aged 50 and over who had received
mixed vaccine doses at a four-week interval• They looked at 2 mixed schedules - P izer followed by AstraZeneca and AstraZeneca
followed by P izer
• Both results in more frequent side-effects after the second dose whencompared to ‘non-mixed’ schedules• This included increase in temporary problems, including fever and fatigue
after receiving the shot
• These adverse reactions ranged from mild to moderate, but were short-lived
and no major safety concerns were found• There are no results yet on how effective the vaccines are when administered in thisway• Data on ef icacy is expected to arrive next month

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Vaccine side-effects• Data from the U.S. Centers for Disease Control and Prevention has shown that more
women than men have reported side effects, such as blood clots and allergic reactions• During the irst month of vaccine administration in the US, 61% of the doses were given
to women, but 72% of the side effects were reported by them

Eugene Consulting Inc.
1602- 111 St. Clair Ave W
Toronto, ONM4V 1N5• However, not all countries had drawn a link between gender, age, and the coronavirus
vaccine• Possible reasons for this are that women are more likely to report side effects and that
estrogen produces a stronger immune reaction against the shot
• Swollen lymph nodes seem to be a more common side effect in women• For women, the side effect of a enlarged lymph node near the breast may resemble
a sign of breast cancer and can lead to false red lags
• For both the AstraZeneca and Johnson & Johnson vaccines, there are reports that involve
extremely rare clotting, including a type of blood clot called cerebral venous sinus
thrombosis, which was seen in combination with low levels of blood platelets, called
thrombocytopenia• With AstraZeneca, most of the cases so fat have been reported by women under 60
years of age within 2 weeks of vaccination• Among possible causes being invested are that the vaccine triggers an unusual
antibody in rare cases• There is however, some voices that suggest it is too early to link gender to the vaccine• In countries where blood clots happened the most and the earliest (Europe),
healthcare workers were being vaccinated with AstarZeneva and healthcare
workers tend to be women• This could meant that the vaccine did not necessarily cause more blood clots inwomen but simply that more women were getting inoculated

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P izer-BioNTech• The study found that approximately 72% of individuals experienced a local side effectafter the irst dose and 69% of individuals experienced a local side effect after theirsecond dose
• The most common side effect = feeling tenderness at the site of injection• 13.5% of people reported experiencing systemic side effects after the irst dose and 22%of people reported experiencing this after the second dose
• The most common side effect was headaches and fatigue• 1.1% of people experienced an allergic reaction in the form of burning of skin after thesecond dose

Eugene Consulting Inc.
1602- 111 St. Clair Ave WToronto, ONM4V 1N5f

AstraZeneca• Nearly 59% of people reported having a local side effect with tenderness being the mostcommon outcome• About 34% of people experienced systemic side effects after the irst dose of theAstraZeneca vaccine, with headaches and fatigue as the leading symptom, followed bychills and shivers• Allergic reactions were rare and less than 2% of people reported skin burning and lessthan 1% reported rashes and red welts on their face and lips

Eugene Consulting Inc.
1602- 111 St. Clair Ave WToronto, ONM4V 1N5ffffff

Ef icacy of COVID-19 Vaccines• If researchers have a well-de ined correlate of protection, they can predict from early trial
data how effective a vaccine will be• This alleviates the need to do larger, more expensive and time- consuming phase IIItrials• Data from seven vaccination trials were examined to help identify a blood marker forprotection against COVID-19• They found a strong link between participants’ antibody levels recorded in earlystage trials and vaccine-ef icacy results from late-stage trials• The researchers estimate that a vaccine has an ef icacy of 50% even if it induces
antibody levels 80% lower than those found, on average, in a person who has
recovered from COVID-19• Vaccines that generated the strongest neutralizing responses, such as the mRNAbased vaccines made by Moderna and P izer-BioNTech were the most protective• The researchers predict that because antibody levels wane over time, booster shots might
be needed in about a year, but protection against severe disease could last many years
even without them
• A study published in the New England Journal of Medicine, following the outcomes ofnearly 40,000 people tested for COVID-19 in Qatar, found that 1 shot of the P izer vaccine
was only 29.5% effective in preventing infection

Eugene Consulting Inc.
1602- 111 St. Clair Ave W
Toronto, ONM4V 1N5f

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• 1 shot of the P izer was found to be 54.5% effective in preventing “severe, critical prfatal” outcomes due to infection by the B.1.1.7 variant• However, of icials in this study followed the dosing direction that the second doseshould be given no more than 21 days after the irst, so this one dose estimate thatwas provided was the ef icacy in the irst 3 weeks immediately after the irst dose
• Among those who received both doses, the study found that the vaccine’s ef icacy
against infection by B.1.1.7 with or without symptoms, was 87%, increasing to 90%
14 days after the second dose
• It was 100% effective against severe symptoms or death• Other studies cited by NACI found a single dose of a coronavirus vaccine to be 65 to 80%
effective in preventing a severe outcome• In Britain, doses have been spaced out by 12 weeks• The WHO has recommended a maximum spacing of 6 weeks, but only in criticalcircumstances• In Ontario where the irst and second dose have been spaced out around 16 weeks, healthof icials have said that they have seen great results from the one-dose only regimen, with
70% ef icacy against infection overall and more than 90% ef icacy against severeoutcomes• The province has seen good levels of immunity starting at 14 days after injection, steadily
increasing up to 28 days after injection• Between mid-December 2020 to late April 2021, nearly 6800 people were infected with
COVID-19 after receiving 1 dose of a vaccine• Among these, 4515 cases were reported within 14 days of their irst vaccine doseand 2274 cases were reported at a minimum of 14 days
• For the B.1.351 variant irst discovered in South Africa, the Qatar study saw poorer
results from one dose
• It was found t one 17% effective in preventing infection and 0% effective inpreventing hospitalization or death due to B.1.351• The Public Health England research found that those who became infected 3 weeks after
receiving their irst P izer-BioNTech or AstraZeneca vaccines were between 38 and 49
percent less likely to pass the virus on to their household contacts compared to others
who were unvaccinated• The shorts also stop pa vaccinated person developing symptomatic infection to start with,
reducing the risk by about 60-65% from 4 weeks after 1 dose of either vaccine• Moderna has announced that its COVID-19 vaccine• was powerfully effective in 12 to 17 year old and plans to apply for FDA authorization• This is based on a clinical trial that enrolled 3,732 people ages 12 to 17, 2/3rds ofwhom received 2 vaccine doses• There were no cases on symptomatic COVID-19 in fully vaccines adolescents, whichtranslates to an ef icacy of 100%• This is the same igure that P izer and BioNTech reported in a trial of theirvaccine in 12 to 15 year old

Eugene Consulting Inc.
1602- 111 St. Clair Ave W
Toronto, ON
M4V 1N5• Federal regulators authorized the P izer-BioNTech vaccine this month for 12-15 year old•
Sano i and GlaxoSmithKline• An experimental COVID-19 vaccine developed by Sano i and GlaxoSmithKline showed arobust immune response in early-stage clinical trial results• This has enabled them to move to a late-stage study• A global Phase III trial will start in the coming weeks and involve more than 35,000adults• This Phase II study will assess the vaccine against various strains including avirus lineage known as B.1.351 irst detected in South Africa• Sano i and GSK last December, were forced to restart their trial when the vaccine showeda low immune response in older adults as a result of a weak antigen formulation• The Phase II interim results showed 95% to 100% seroconversion following a second
injection in all age groups and across all doses, with acceptable tolerability and no safetyconcerns• Seroconversion is the vaccine’s ability to prompt the body to produce antibodies
against the coronavirus, as measured by blood readings• They also observed that the vaccine generated a higher antibody response in those with
precious COVID-19 infection• This is being analyzed further as it may suggest that the vaccine can serve as apotential booster• The GSK and Sano i vaccine candidate uses the same technology as one of Sano i’sseasonal in luenza vaccines and it will be coupled with an adjuvant - a substance that acts
as a booster to the shot
• So far, Sano i has purchasing agreements with the U.S, the EU, Britain, and Canada, as wellas with the WHO-backed COVAX facility• Sano i is also working on a mRNA candidate with U.S. company, Translate Bio for which it
has started clinical trialsfffff

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COVID-19 Vaccine Protection Period• P izer and BioNTech has stated that data from their Phase 3 trial showed high levels ofprotection against COVID 6 months after 2nd doses• There is other research backing up the claim that the Moderna vaccine offers protectedagainst COVID-19 for at least 6 months• These reports were based on follow-up tests in dozens of people who received the shorts
during studies that led to the vaccines’ use• These were done before troubling new variants or versions of the coronavirus, hademerged and started to spread• The FDA’s top vaccine regulator has stated that a COVID-19 booster shot could be needed
for fully vaccinated people within a year

Eugene Consulting Inc.
1602- 111 St. Clair Ave W
Toronto, ON
M4V 1N5• P izer-BioNTech is testing a third booster shot of its vaccine on fully vaccinated people• Moderna is also testing a potential third dose of its current vaccine and a possible booster
shot speci ically targeting the South Africa variant• There is less data available for the AstraZeneca vaccine, however, when looking at theeffectiveness of the vaccine after giving the 2 doses at different intervals, studies haveshown that the vaccine ef icacy reached 82.4% after a second dose for those who had adosing interval of 12 weeks or more
• This means that it is reasonable to think the protection will last at least a further 3months after the second dose, although more data is needed• While it is possible that vaccine-induced protection will last longer than the 6 months
being proposed by these indings, many experts believe that the antibodies created byvaccines will wane over time and booster shots will be required• If vaccines need to be tweaked to be more effective against new variants manufacturers
have said that these will be easy to do and can be done in less than 3 months

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General COVID-19 News
• WHO director general Tedros Adhanom Ghebreyesus has warned that the world reminds
in a very dangerous situation where more cases have been reported so far this year thanin the whole of 2020
• According to current trends, the number of deaths will overtake last year’s total within
the next 3 weeks• More than 75% of all vaccines have been administered in just 10 countries• WHO is urging countries to donate vaccine doses to COVAX to enable 10% of the
populations of all countries to be inoculated by September and 30% by year’s end• In Europe, British scientists say that sniffer dogs trained using smelly socks worn bypeople infected with the SARS-CoV-2 virus could soon be used yo pick up the “coronaodour” of those infected with the virus• They say that these dogs can screen a line of several hundred people coming off aplane within half an hour, and detect with up to 94.3% sensitivity those infected• These researchers presented results of an early-stage study which involved some3500 odour samples donated in the form of unwashed socks or T-shirts• They say these dogs were even able to sniff out asymptomatic or mild COVID-19cases, as well as cases caused by a variant that emerged in the U.K. last year
• While India is currently at the epicentre of the global coronavirus pandemic, it is not the
only country with a worsening COVID-19 outbreak• Argentina, Bahrain, Taiwan, and Nepal, as well as many other countries havereported record increases in cases in the last few weeks• These are generally countries that are lagging in vaccinating their populations due
to limited supply of shots• Federal health of icial have stopped investigating breakthrough coronavirus infections invaccinated people unless the cases cause serious disease that lead to a hospitalization ora deathEugene Consulting Inc.
1602- 111 St. Clair Ave W
Toronto, ON
M4V 1N5ff• They will continue to gather data about mild breakthrough cases that are reported
to the agency but will only investigate the most serious cases• Until May, the agency was monitoring all cases• Although they will continue to carry out vaccine effectiveness studies, it will focus
on speci ic populations like health care workers, essential workers, the elderly andresidents of long-term care facilities• Some criticize this move saying it is wasting an opportunity to learn about the realworld effectiveness of different vaccines, gather information on when vaccine
protection begins to wane, whether variants play a signi icant role in breakthroughinfections, and if some patient are more susceptible than others to the post-vaccine
infection• Others understand that they need to prioritize and focus on understanding thecases associated with severe disease