Eugene Consulting Inc.
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June/July 2022 Report
COVID booster shot updates
https://www.cbc.ca/news/health/fda-vaccine-omicron-1.6505039 - June 29, 2022
- The FDA's Vaccines and Related Biological Products Advisory Committee voted 19-2 thatthe next wave of COVID booster shots should include a component that targets the
Omicron variant of the coronavirus- The agency plans to decide by early July on what the design of the boosters should be- The CDC states that the BA.4 and BA.5 sub-variants of Omicron are estimated to make up
a combined 52 per cent of the coronavirus cases in the United States as of June 25- Moderna has said that they can be ready with a couple hundred million of doubletargeted vaccines designed to combat BA.1 by September, however that if they need todesign a vaccine targeting the newer sub variants, it would be late October of earlyNovember- Prize and BioNTech have also stated that they have a signi icant amount of BA.1 vaccine
ready and are preparing to produce a large amount of vaccine targeting BA.4 and BA.5
- Either could be ready by early October- They have also said that their BA.1-inclusive vaccines generated a better immune
response against Omicron than their current shots, which were designed for theoriginal virus

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BioNTech, P izer’s universal vaccine for coronaviruses
https://www.reuters.com/business/healthcare-pharmaceuticals/biontech-p izer-startingtesting-universal-coronavirus-vaccine-h2-2022-06-29/ - June 29, 2022
https://www.medicalnewstoday.com/articles/p izer-and-biontech-to-test-universalcovid-19-vaccine-candidate - July 7, 2022
- While 2 doses of an mRNA COVID-19 vaccine were 85% effective in preventing hospital
admission for infection with the Alpha and Delta variants of SARS-CoV-2, they were only
65% effective in doing so following an Omicron infection- To try and overcome waning COVID-19 vaccine ef icacy, researchers at P izer and
BioNTech are developing a universal COVID-19 vaccine The 2 companies announced a
new clinical trial for universal COVID-19 vaccine candidates in the second half of 2022
- Their experimental work on shots include T-cell-enhancing shots designed to primarily
protect against severe disease and pan-coronavirus shots that protect against the broader
family of viruses and its mutations- The hope is that a universal coronavirus vaccine has the potential to better protect
against future variants of SARS-CoV-2 as well as other coronaviruses- However, just how universal such a vaccine would be is debatable- BioNTech has also announced that they are independently working on precision
antibiotics that kill superbugs that have grown resistant to currently available antiinfectives

- They will be leaning on the technology of PhagoMed, which they acquired backed in
October last year
Moderna COVID-19 Vaccine- Moderna’s COVID-19 vaccine may pose a higher risk of heart in lammation in some agegroups than P izer-BioNTech’s shot
- The CDC however has said that the indings on myocarditis and pericarditis, types ofheart in lammation linked to both the mRNA shots, were not consistent across all of the
U.S. vaccine safety monitoring systems- Based on data from the Vaccine Safety Datalink (VSD) system, the incidence of heartin lammation was 97.3 cases per million doses for males aged 18-39 following a second
dose of Moderna's shot, versus 81.7 cases per million P izer vaccine doses- Available information suggests that most people with myocarditis after mRNA COVID-19
vaccination recover over time
COVID-19 Vaccine for Children Aged 6 Months to 4 Years
https://www.cbc.ca/news/health/fda-authorizes-covid-19-vaccines-kids-under- iveus-1.6492142- On June 17th, the FDA accepted its advisory panel’s unanimous recommendation for thepaediatric shorts from Moderna and P izer-BioNTech- Kids between 6 months and 4-years and a half in the U.S will now be eligible for their irst
COVID-19 vaccinations- Paediatric deaths from COVID-19 have been higher than what is generally seen from thelue each year
- Studies from Moderna and P izer show that possible vaccine side effects including fever
and fatigue were most minor- P izer’s vaccine for kids younger than 5 will be 1/5th of the adult dose
- 3 shots are needed - the irst 2 given 3 weeks apart and the last at least 2 months
later- Moderna’s is 2 shorts, each a quarter of its adult dose, given about 4 weeks apart for kids
under 6
- On July 28th, Health Canada also approved Moderna’s paediatric shot

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Emergency use authorization of Novavax
https://www.ctvnews.ca/health/coronavirus/u-s-fda-gives-emergency-use-authorizationto-novavax-s-covid-19-vaccine-1.5986356 - July 13, 2022
https://www.yalemedicine.org/news/novavax-covid-vaccine - July 20, 2022
- The U.S. FDA has authorized Novavax’s COVID-19 vaccine for emergency use in adults- This is the 4th coronavirus vaccines available in the U.S.
- The vaccine will be available as a 2-dose primary series for people 18 and older- Novavax’s vaccine is a protein-based vaccine which uses harmless protein fragments ofthe virus to teach the immune system how to spot the virus and ight it offff

Eugene Consulting Inc.
408-25 Montgomery Ave
Toronto, ON
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Eugene Consulting Inc.
408-25 Montgomery Ave
Toronto, ON
M4R 0A1- It was created out of a genetic sequence of the irst strain of the coronavirus- Last-stage trials found that the ef icacy of the vaccine against mild, moderate and severe
disease is 90.4%- There is no suf icient evidence to evaluate the impact of the vaccine on transmission of
the virus- The company announced that its vaccine shows broad immune response to currently
circulating variants including Omicron sub variants BA.4/5- The Novavax vaccine is being used in 40 other countries, including Canada- In the clinical trial, the most commonly reported side effects were pain/tenderness,redness and swelling at the injection site, fatigue, muscle pain, headache, joint pain,
nausea/vomiting, and fever- Myocarditis occurred in a handful of Novavax clinical trial participants, all of whom weremen, but there is insuf icient evidence to establish a causal relationship between thevaccine and the contain so the FDA decided the bene its of the vaccine outweigh the risks- Similar reports have risen around the mRNA vaccines and the FDA has issued a warninglabel on both the P izer and Moderna vaccines regarding myocarditis and pericarditis inadolescents and young adults

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COVID-19 Vaccines and Pregnancy
https://hms.harvard.edu/news/covid-19-vaccines-pregnancy- Pregnant individuals and newborns may face elevated risks of developing more severecases of COVID-19 following SARS-CoV-2 infection, but research suggests that COVID-19
vaccination during pregnancy can help protect both the person giving birth and the child- A new study led by investigators at Harvard Medical School, Massachusetts General
Hospital, and Brigham and Women’s Hospital and published June 28 in Nature
Communications examined how different COVID-19 vaccines and the timing ofvaccination during pregnancy may impact the extent of this protection- The team also evaluated the transfer of protective SARS-CoV-2 antibodies via the placenta
from the pregnant person to the fetus by analyzing blood from the umbilical cord and theperson giving birth in 175 pairs- The research revealed that the Johnson & Johnson vaccine induced lower-functioning
SARS-CoV-2-speci ic antibodies than the Moderna and P izer-BioNTech vaccines- The Moderna vaccine provided subtle advantages in antibody levels and function
compared with the P izer-BioNTech vaccine- Additionally, the mRNA-based vaccines induced higher levels and functions of antibodies
against SARS-CoV-2 variants of concern, including alpha, beta, delta, and gamma- All three vaccines also induced antibodies that demonstrated neutralizing activity against
omicron- Pregnant people vaccinated during the irst and third trimesters had enhanced immune
responses compared with second trimester vaccination- SARS-CoV-2-speci ic antibodies were most ef iciently transferred to the fetus through theplacenta following vaccination during the irst and second trimestersEugene Consulting Inc.
408-25 Montgomery Ave
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M4R 0A1- Additional studies are needed to understand how to optimize maternal and neonatal
immunity induced by vaccines in general during pregnancyInvestigators stressed theneed for more research on this topic.

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COVID-19 During Pregnancy: Increased Risk of Preterm Delivery and Infancy
Neurodevelopmental Issues - June 27, 2022
https://www.forbes.com/sites/williamhaseltine/2022/06/27/covid-19-duringpregnancy-increased-risk-of-preterm-delivery-and-infant-neurodevelopmental-issues/?
sh=60a015d5358b- Pregnant women are at a high risk contracting disease, including COVID-19- Researchers at the University College London suggest that mothers who catch COVID-19
during their irst trimester are more likely to have an early miscarriage- Another study led by a group at Harvard Medical School found that infants born tomothers who had COVID-19 during pregnancy are more likely to receive aneurodevelopmental diagnosis in the irst 12 months following delivery- Maternal vaccination has shown to help cut down many of the risks associated with SARSCoV-2 infection during pregnancy- Between May and December of 2020, Balachandren et al. recruited 3500 women via
social media to help participate in the COVID-19 Contraception and Pregnancy Study- All women had conceived during the pandemic and were within the irst 12 weeks
of pregnancy- The team of researchers asked the women to report on any current or priorpregnancy complications and their medical history- The participants were also asked every trimester whether they or anyone in theirhousehold had been diagnosed with SARS-CoV-2 infection- Depending on their answer, the women were iltered into one of three groups: those
who self-reported a SARS-CoV-2 infection within the irst trimester (“presumed
infected”), those who had symptoms or were exposed to household contacts withsymptoms but had no of icial diagnosis (“uncertain”), and those who had neither
symptoms nor household contacts with symptoms (“presumed uninfected”)- After accounting for age, body mass index (BMI), number of previous miscarriages,
ethnicity, and smoking status, Baachandren and his colleagues discovered that therisk of early miscarriage was around 1.7 times higher in the “presumed infected”
group — a rate of 14%, compared to 8% in the “presumed uninfected” group and
5% in the “uncertain” group- How SARS-CoV-2 infection during the irst trimester contributes to early miscarriage is
not entirely clear- Researchers propose that cytokines may be involved as coronaviruses have also
been shown to induce a pro-in lammatory cytokine storm in the body
- The researchers stress that they have not established a strict causal relationship between
Covid-19 and early miscarriage, but rather a correlation between the two- Further research will be needed to prove that SARS-CoV-2 is directly at fault

Pregnant women and booster dose
https://www.nihr.ac.uk/news/covid-19-vaccine-study-calls-on-pregnant-women-to-helpbuild-upon-booster-dose-guidance/30869 - July 19, 2022
- An on-going national COVID-19 vaccine study in the UK, Preg-CoV study, is urging morepregnant women across the UK to help researchers discover the most effective use ofbooster vaccines during pregnancy- They currently have around 300 pregnant women taking part
- The study is led by researchers at St. George’s University of London- It is comparing vaccine currently being used for the UK vaccination programs (P izer/
BioNTech and Moderna) as well as new vaccines as they are approved for use, such as
Novavax- The study will also provide vital clinical trial data on the immune response to booster
vaccination with different doses of vaccines as well as the immune response to different
intervals between doses given in pregnancy- COVID-19 vaccines are safe and effective for pregnant women, and there is a clinicalconsensus that it is the best way to protect pregnant women and their babies fromCOVID-19

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PhagoMed Biopharma GmbHhttps://www.mobihealthnews.com/news/emea/biontech-acquires-eit-health-startupight-against-bacterial-infections
https://amr-conference.com/news/biontech-acquires-vienna-based-start-up-phagomed/- A Vienna-based biotech company that was developing novel synthetic lysin technology
for precision antimicrobial treatments- Lysin are enzymes produced by bacteriophages that break down bacterial cell walls
and kill bacteria- The advantages of lysins is that they are very precise and therefore only kill speci ic
groups of bacteria- PhagoMed’s Lysin builder platform allows for the development of synthetic lysins thatcreate targeted antibacterials- The Lysin Builder uses prediction algorithms to design novel precision antibiotics
that target and kill select groups of bacteria- As a result of antimicrobial resistance, some infections are much harder to treat or
respond to treatment- Therefore, science and innovation are needed to ind new and alternative solutions
to antibiotics that are losing effectiveness- PhagoMed joined the European Institute for Innovation and Technology’s Gold Trackprogramme in June 2020 and were supported over a period of 12 months- The company’s lead lysin candidate is PM-477, which targets Gardnerella app for thetreatment of recurrent bacteria vaginosis- On November 10th, 2021, PhagoMed was acquired by BioNTech- Terms of the transaction were not disclosedffEugene Consulting Inc.
408-25 Montgomery Ave
Toronto, ON
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Eugene Consulting Inc.
408-25 Montgomery Ave
Toronto, ON
M4R 0A1- This acquisition can be interpreted as their entry into the microbiome ield

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Phage Therapy Case Studies show success rate of more than half
https://www.genengnews.com/topics/translational-medicine/infectious-diseases/phagetherapy-case-studies-show-success-rate-of-more-than-half/ - June 10, 2022
- A research team led by scientists from the University of Pittsburgh and the University ofCalifornia San Diego reported 20 new case studies on the use of phage therapy, showing
success in more than half of the patients- It is reportedly the largest ever set of published case studies for therapy using
bacteriophages- Each patient in the study was seeking care for an infection of one or more strains of
Mycobacterium, a group of bacteria that can cause deadly, treatment-resistant infectionsin those with compromised immune systems or with cystic ibrosis- While some show great outcomes, others are complicated, however, the 20 case studies
show compelling evidence that the phages are contributing to favourable outcomes inpatients who have no other alternatives- Bacteriophage therapy represents a potentially novel approach to treating nontuberculous Mycobacterium infections- Mycobacterium isolates from 200 culture-positive patients with symptomatic disease
were screened for phage susceptibilities and one or more lytic phages were identi ied for
55 isolates- Phages were administered intravenously, by aerosolization, or both to 20 patients on acompassionate use basis and patients were monitored for adverse reactions, clinical andmicrobiologic responses, the emergence of phage resistance, and phage neutralization inserum, sputum, or bronchoalveolar lavage luid
- No adverse reactions attributed to therapy were seen in any patient regardless of thepathogen phages administered, or the route of delivery- Favourable clinical or microbiological responses were observed in 11 patients- Neutralizing antibodies were identi ied in serum after initiation of phage delivery
intravenously in eight patients, potentially contributing to lack of treatment response infour cases but were not consistently associated with unfavourable responses in others- Phage treatment of Mycobacterium infections is challenging due to the limited repertoireof therapeutically useful phages, but favourable clinical outcomes in patients lacking anyother treatment options support continued development of adjunctive phage therapy forsome mycobacterial infections- In 11 cases, researchers were unable to ind more than 1 kind of phage that could kill thepatient’s infection- While standard practice is to inject a cocktail of different viruses, they did notobserve failure of treatment from resistance even when using only a single phage- Some patients’ immune systems attacked the viruses, but only in a few cases did theirimmune systems render the virus ineffective

Eugene Consulting Inc.
408-25 Montgomery Ave
Toronto, ON
M4R 0A1- In some instances, the treatment was still successful despite such an immune
reactionfffPersonalized bacteriophage therapy to treat pandrug-resistant spinal Pseudomonas
aeruginosa infection
https://www.nature.com/articles/s41467-022-31837-9 - July 22, 2022
- Bone and joint infections (BJI) are one of the most dif icult-to-treat bacterial infection,
especially in the era of antimicrobial resistance- Lytic bacteriophages are considered to have a high therapeutic potential for the treatment
of severe bacterial infections and especially BJI, as they also target bio ilms
- Lytic bacteriophages can rapidly and selectively target and kill bacteria whilst producing
new phage particles in an exponential and self-sustained reaction- A 74-year-old man with melanoma treated with anti-PD1 (pembrolizumab) experienced acatheter-related bacteremia due to multidrug-resistant P. aeruginosa- A unique academic collaboration between universities and hospitals located in threedifferent European countries (Switzerland, Belgium, and France) allowed researchers to
identify three different lytic phages active on the patient initial P. aeruginosa isolate, toproduce them separately, and to administer them as a pre-assembled personalized threephage cocktail to the patient, in the shortest possible time
- The phage cocktail was locally administered (same volume and phage concentration)
before insertion of the intersomatic cages at L2-L3 and L3-L4 level- As the cultures revealed persistence of the P. aeruginosa, phages were also added
intravenously over 3-h infusions (30 mL, phage titers 106 pfu/mL) every day for 21 days
- Under this treatment, the patient experienced abdominal pain related to gall stone
migration and relapsing C. dif icile infection- No adverse event potentially related to phage therapy was noticed- The outcome was favorable during the follow-up (21 months), without implant loosening
nor clinical signs of infection (Fig. 2C, D), and the patient was walking without pain