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Summary of the Vaccine Safety Net Resources

Author: Task Force Vaccine

Published: 18/01/2021

Ref: 0006 EN

All following results on efficacy in the clinical trials have been obtained in the same level, in all groups, ethnicities, and genders.

Moderna vaccine

• Moderna vaccine efficacy was tested on 30,000-person. Only 11 who received the vaccine developed symptoms after being infected vs. 185 in a placebo group. That is an efficacy of 94.1%!

• Moderna’s vaccine showed 100% efficacy against severe forms of the disease: 0 such cases among those vaccinated vs. 30 in the placebo group, inc. 1 death from the disease.

Pfizer-BioNTech vaccine

• Pfizer vaccine was tested on 45,000-person and its efficacy was of 95%.

• Half participants received injections and half placebo. There were 8 cases of Covid among vaccinated people vs. 162 on placebo**. 10 severe cases occurred with just 1 in the vaccinated group.

Further assessments More CDC and manufacturers assessments will take place to better understand the protection of the vaccines under real conditions, outside of clinical trials.

Many factors can affect effectiveness in real-world situations like the way a vaccine is transported and stored, the way patients are vaccinated etc...

Complementary studies will help to furthermore explore questions such as: how long will the vaccine provide protection? can vaccinated people transmit the virus? which categories of people among those who were not included or not well represented in the clinical trials could safely be vaccinated?

FDA : Emergency Use Authorization (EUA) for an Unapproved Product Review Memorandum https://www.fda.gov/media/144416/download

UK Government : COVID-19: the green book, chapter 14a https://www.gov.uk/government/publications/covid-19-the-green-book-chapter-14a

New England Journal of Medicine: Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine https://www.nejm.org/doi/full/10.1056/NEJMoa2034577

ScienceMag :

‘Absolutely remarkable’: No one who got Moderna’s vaccine in trial developed severe COVID-19 https://www.sciencemag.org/news/2020/11/absolutely-remarkable-no-one-who-got-modernas-vaccine-trial-developed-severe-covid-19

• What about medication? As for today, some treatments and medication help in assisting COVID patients but none of them has proven full efficacy in treating patients with severe symptoms and preventing complications or death. It is therefore crucial to stop the pandemic. But, as for today, no treatment has been proven effective to prevent the infection.
  

• What about vaccines? Clinical trials of the vaccines showed vaccinated persons were protected from getting Covid with a very high efficacy (up to 95% with the Pfizer-BioNtech and Moderna vaccines) Therefore, the vaccine is the most advanced way to end the pandemic.
  

• What about the wearing of mask on mouth and nose and social distanciation*? Those measures help reduce our risks of being exposed to the virus or spreading it to others, But, only associated to COVID vaccination, will those measures offer the best protection from COVID,

*staying at least 6 feet/2 meters away from others.

CDC : https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mrna.html

Author:Task Force Vaccine

Published: 20/01/2021

Ref: 0001 EN

It is the nature of science to make hypotheses and try to verify them.

“A theory that is not refutable by any conceivable event is non-scientific. Irrefutability is not a virtue of a theory (as people often think) but a vice. (...) The criterion of the scientific status of a theory lies in its falsifiability, or refutability, or testability.“ (Karl Popper) In physics, for instance, a theory is valid as long as the results of the equations fit with the results of the experiments.

In vaccine science, a vaccine is considered legitimate if it is safe and effective. It is scientifically correct to evaluate Covid vaccines according to these criteria and then to discuss the sample size and the monitoring time allowing to include these vaccines in the therapeutic arsenal.

It is therefore normal and even recommended that scientists "argue". But it is dangerous for them to do so publicly because their field of expertise involves complex notions and a specific language that only them are able to understand. Putting up contradictory arguments is legitimate, but making it publicly invalidates public confidence.

A physician or scientist should not use social networks to express non-evidence based theories in conflict with Public Health decisions, especially during a global pandemic. By doing so, he or she is participating in what he or she denounces.

Author: Menahem Bregegere,PhD,

Contributors: Irene Fermont MD, MSC, Ayalah Livneh MD, MSc

Published : 31 January 2021

Update: 07/03/2021

0027 EN

Virus mutations are errors in the replication of their genetic material. Most are harmless, but some can change virulence, and/or virus susceptibility to the immune response.(1)

The COVID-19 "Spike" is a strategic protein, by which the virus binds to the "ACE2" receptor of the cells it infects, in order to enter them. Spike affinity for the receptor is accountable for virulence.(2) Spike is the preferred target of anti-viral immunity. Therefore Pfizer and Moderna have chosen its messenger RNA as the active ingredient of their vaccine, in order to trigger an intense and well-targeted immune response.(3)

In September 2020, a high virulence variant of COVID-19, "B.1.1.7", appeared in Great Britain. It has spread rapidly, and is accountable today for the majority of new infections in Israel. This variant contains 17 mutations, compared with the original Wuhan strain, including several in the receptor binding domain of Spike – the area of contact with the cell it infects. These mutations are likely to increase virulence.(4)

They are also likely to let the virus escape the immunity acquired from a primary infection with the original virus, or from a vaccination. However, laboratory experiments with the B1.1.7 variant showed that the neutralizing power of antisera from convalescent COVID, or from people vaccinated with Pfizer or Moderna vaccines, was barely attenuated.(5) The protection provided by the vaccines against this variant is therefore essentially intact.

The main problem raised by B1.1.7 is its high transmissibility, which increases contagion and multiplies the number of patients at all levels of severity.(6) In addition, health authorities also raise the possibility of higher virulence, with serious complications observed in pregnant women, and possibly also in children,(7) (8). Finally, preliminary results suggest that this variant tends to increase COVID severity and death rate.(9)

1) cles/d41586-020-02544-6 Callaway, E. 2020. Making sense of coronavirus mutations. Nature 585, 174-178. https://www.nature.com/arti

2) Starr, T. N., Greaney, A. J., Hilton, S. K., et al. 2020. Deep mutational scanning of SARS-CoV-2 receptor binding domain reveals constraints on folding and ACE2 binding. Cell 182 (5) 1295-1310. https://www.cell.com/cell/fulltext/S0092-8674(20)31003-5

3) Du, L., He, Y., Zhou, Y., et al. 2009. The spike protein of SARS CoV – a target for vaccine and therapeutic development. Nature Reviews Microbiology 7, 226-236. https://www.nature.com/articles/nrmicro2090

4) Corum, J., Zimmer, C. 2021. Inside the B.1.1.7 coronavirus variant. The New York Times (18/01/2021. https://www.nytimes.com/interactive/2021/health/coronavirus-mutations-B117-variant.html

5) Muik, A., Wallischn A. K., Sänger, B., et al. 2O21. Neutralization of SARS-CoV-2 lineage B.1.1.7 pseudovirus by BNT162b2 vaccine-elicited sera. Science 10.1126/science.abg6105 (2021) https://science.sciencemag.org/content/early/2021/01/28/science.abg6105

6) Galloway, S. E., Prabasaj, P., Mac Cannel, D. R., et al. 2021. Emergence of SARS-CoV-2 B.1.1.7 Lineage — United States, December 29, 2020–January 12, 2021. CDC – Morbidity and Mortality Weekly Report. https://www.cdc.gov/mmwr/volumes/70/wr/mm7003e2.htm

7) Christensen, J. 2021. CDC doesn't know if new Covid-19 variants are causing rare complication in children. CNN Health (27/01/2021) https://edition.cnn.com/2021/01/27/health/new-covid-variant-complications-children-wellness/index.html

8) Jaffe-Hoffman, M. 2021. Coronavirus: Gov't to vote on full closure of airport today. Jerusalem Post (24/01/2021) https://www.jpost.com/health-science/coronavirus-six-pregnant-women-in-serious-condition-have-uk-variant-656461

9) Iacobucci, G. 2021. Covid-19: New UK variant may be linked to increased death rate, early data indicate. British Medical Journal, 372, n230

https://www.bmj.com/content/372/bmj.n230

Another variant appeared in South Africa in October 2020, named "501Y.V2". This variant has some mutations of the Spike in common with B.1.1.7, as well as an increased transmissibility, and it has more mutations in the Spike (8 in all) (10) , that allow it to partially escape immunity acquired from a primary infection(11). Laboratory studies have shown that sera from people who have received Pfizer or Moderna vaccines partially neutralize viruses carrying the 501.Y.V2 mutations (12) (13). But these results cannot simply be extrapolated to real life, leaving us in doubt about the effectiveness of these vaccines on the variant.

Other variants with increased transmissibility have appeared, notably the Brazilian variant P.1, which has many features in common with 501.Y.V2 although it appeared independently;(14) the California variant CAL.20C, which shares mutations with B.1.1.7;(15) and probably others still, which have not yet been characterized. All these variants are already present in Israel, although in marginal amounts, and are expected to spread in the coming period. They therefore constitute a challenge that we will have to take in the near future.

To achieve this, vaccines and social distancing measures are good tools. A major advantage of the mRNA vaccine is its adaptability: virus attempts to evade immunity can be thwarted by using an mRNA where variant mutations have been introduced. The site-directed mutagenesis technique makes this possible in a very simple manner.(16) Therefore Ugur Sahin, CEO of BioNTech, could say that he was "technically capable of delivering a new vaccine in six weeks".(17)

The battle against the pandemic is therefore not over. It is well underway, but we have not yet won the war.

10) Tegally, H., Wilkinson, E., Giovanetti, M., et al. 2020. Emergence and rapid spread of a new severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2) lineage with multiple spike mutations in South Africa. medRxiv Preprint doi:

https://www.medrxiv.org/content/10.1101/2020.12.21.20248640v1

11) Wibmer, C. K., Ayres, F., Hermanus, T., et al. 2021. SARS-CoV-2 501Y.V2 escapes neutralization by South African COVID-19 donor plasma. bioRxiv Preprint doi: https://www.biorxiv.org/content/10.1101/2021.01.18.427166v2

12) Pfizer. In vitro studies demonstrate Pfizer and BioNTech vaccine elicits antibodies that netralize SARS-CoV-2 with key mutations present in U.K. and South African variants. 27/01/2021.

https://www.pfizer.com/news/press-release/press-release-detail/vitro-studies-demonstrate-pfizer-and-biontech-covid-19

13) Moderna Inc. Moderna COVID-19 vaccine retains neutralizing activity against emerging variants first identified in the U.K. and the Republic of South Africa. 25/01/2021.

https://investors.modernatx.com/news-releases/news-release-details/moderna-covid-19-vaccine-retains-neutralizing-activity-against/

14) Faria, N., Claro, I. M., Candido, D., et al. 2020. Genomic characterisation of an emergent SARS-CoV-2 lineage in Manaus: preliminary findings. Virological.org. https://virological.org/t/genomic-characterisation-of-an-emergent-sars-cov-2-lineage-in-manaus-preliminary-findings/586

15) Zhang, W., Davis, B. D., Chen, S. S., et al. 2021. Emergence of a novel SARS-CoV-2 strain in Southern California, USA. medRxiv Preprint doi: https://doi.org/10.1101/2021.01.18.21249786

16) Hemsley, A, Arnheim, N., Toney, M. D., et al. 1989. A simple method for site-directed mutagenesis using the polymerase chain reaction. Nucleic Acids Research 17 (16), 6545-6551. https://pubmed.ncbi.nlm.nih.gov/2674899/

17) Jordans, F. 2020. BioNTech CEO confident vaccine will work on UK variant. AP News, December 22, 2020. https://apnews.com/article/europe-europe-coronavirus-pandemic-united-states-8555f433c0cd8ea8c58040e3f7aa0e91