Categories
COVID-19 Pharmaceuticals

The Future of Vaccine Companies: Unceasing Competition

Seonhwa Lee—McMaster Honours Human Behaviour 2024

With decreasing trend in infection cases and lighter restrictions following the expedite development of effective vaccine supply, it seemed like the world was finally coming back to normal. This hope is now shattered with the recent emergence of omicron, the new variant of COVID virus. At this time of inflection, what is the future of major vaccine companies?

Engaging Variant and Booster Vaccines

Omicron varies from other COVID viruses in its numerous mutations in the spike protein, which the vaccine aims to mimic to produce antibodies. In fact, studies were conducted by Pfizer and BioNTech to see a significant decrease in the number of virus-targeting antibodies in omicron (1). They also found evidence to support the efficacy and efficiency of booster shots in increasing the production of antibodies as well (1). Booster shot is injected after an individual has received one or two previous doses of regular vaccine against COVID depending on the type.

SOURCE: The Sudbury Star

The Canadian government had authorized companies producing viral vector-based vaccines such as Janssen and AstraZeneca for adults over 18 years of age, and mRNA vaccines such as Moderna and Pfizer and BioNTech (2-5). mRNA vaccines were given full approval to give children over 5 (Pfizer-BioNTech) and 12 (Moderna) with reduced dose, and Spikevax by Moderna was especially approved as a booster shot in November (4-6). Pfizer and BioNTech is also planning to drop their new vaccine adjusted to target omicron in March 2022 depending on the need, as well as 4 billion more of their current Comirnaty vaccine supply (1).

Antiviral Pills

 Aside from vaccines, companies are also striving to develop pills to cure. Pfizer is in the lead among major companies with their two-pill antiviral named Paxlovid, which showed outstanding efficacy by dropping hospitalization and death by 89% (1). Paxlovid is used to treat relatively mild symptoms in unvaccinated individuals and the above-mentioned result was when patients took the pill within three days of symptoms (1).

Merck also dropped a one-pill antiviral called Molnupiravir less impact than Paxlovid by reducing hospitalization and death by 30% when taken within five days after symptoms first appeared but is still clearly in lead compared to other companies (1).

Progress on making the most effective vaccine or cure is a key factor in the inevitable competition among these pharmaceutical companies.

Side Effects and Post-Pandemic

Despite the fact that all types of vaccine currently used by countries are authorized and approved for its “safety”, current vaccines are suspected of possible side effects spanning from light redness and swelling to serious hear inflammation (7).

SOURCE: Today Show

Once confirmed cases decrease again and the pandemic gets closer to the end, the corporates will likely have a decreased stock value and maybe change the price to directly target the public with COVID products remaining on the market and focusing more on regular products they had before the virus; if they are still authorized despite the side effects with no immediate threat.

References

  1. Gatlin A. Is Pfizer stock a buy as omicron partially eludes its Covid vaccine? [Internet]. Investor’s Business Daily. 2021 [cited 2021Dec11]. Available from: https://www.investors.com/news/technology/pfizer-stock-buy-now/
  2. Canada H. Government of Canada [Internet]. Canada.ca. / Gouvernement du Canada; 2021 [cited 2021Dec11]. Available from: https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/vaccines/janssen.html
  3. Canada H. Government of Canada [Internet]. Canada.ca. / Gouvernement du Canada; 2021 [cited 2021Dec11]. Available from: https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/vaccines/astrazeneca.html
  4. Canada H. Government of Canada [Internet]. Canada.ca. / Gouvernement du Canada; 2021 [cited 2021Dec11]. Available from: https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/vaccines/moderna.html
  5. Canada H. Government of Canada [Internet]. Pfizer-BioNTech Comirnaty COVID-19 vaccine – Canada.ca. / Gouvernement du Canada; 2021 [cited 2021Dec11]. Available from: https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/vaccines/pfizer-biontech.html
  6. Canada H. Health Canada authorizes the use of the Moderna Spikevax COVID-19 vaccine as a booster shot [Internet]. Canada.ca. Government of Canada; 2021 [cited 2021Dec11]. Available from: https://www.canada.ca/en/health-canada/news/2021/11/health-canada-authorizes-the-use-of-the-moderna-spikevax-covid-19-vaccine-as-a-booster-shot.html
  7. Gatlin A. Is moderna stock a buy or sell as shares Yo-Yo on the omicron threat? [Internet]. Investor’s Business Daily. 2021 [cited 2021Dec11]. Available from: https://www.investors.com/news/technology/mrna-stock-buy-now/
Categories
COVID-19 mRNA

mRNA Vaccines and the Future of Vaccination

Rodrigo Hontoria — McMaster University Honours Life Sciences 2023

Over the past 3 decades, scientists have been working with messenger RNA (mRNA) as a potential new method of producing simpler and more effective vaccines1 2. mRNA is a promising topic to assess because of its ability to produce a vast number of proteins, all depending on the coding of each mRNA. In a cell, mRNA is transcribed from DNA and undergoes a series of modifications that provide protection from the cellular environment, before finally being released into the cytoplasm for translation. Incorporating mRNA into modern vaccinations would provide three very beneficial outcomes:

  1. Safety – unlike other vaccines that require a weakened/damaged strain of the virus, mRNA vaccines provide a non-infectious route to immunity1 2. Also, after translation has occurred, mRNA is quickly degraded by the cell avoiding any long-lasting effects1.
  1. Efficacy – mRNA vaccines provide a highly detailed method for producing an immune response by inducing the production of whichever desired viral protein. In other words, mRNA strands can be made to encode the exact viral protein, without any of the deleterious and self-replicating genes of the virus. The lifespan/stability of mRNA can also be adjusted through changes in its 5’ cap and poly-A tail, or carrier molecule to change the time span of its desired effects2.
  1. Cost of production – Synthetic viral mRNAs are significantly less costly to produce compared to the manufacturing of proteins and viral antigens1.
A diagram of an mRNA vaccine in action. It shows a synthetic mRNA being translated by a ribosome into individual proteins from SARS-CoV-2, which induce an immune response.
Source: The Conversation

Setbacks and Advancements

In 1990, a group of scientists performed the first successful mRNA injection using reporter genes to induce the production of the corresponding proteins in mice1. In follow up experiments, physiological effects were observed in mice after the uptake of synthetic mRNA that stimulates the release of different hormones1 2. Although these early successes were very exciting and provided a potentially prosperous technology, many advancements in research were still necessary to achieve safety and efficiency. mRNA vaccine setbacks have been outlined thoroughly in past research projects, some of the most notable being: 

  1. Passage of mRNA from the bloodstream into the cell – through vaccination, mRNA will directly enter the bloodstream but how will cells be encouraged to uptake the mRNA?
  1. Stability/protection of mRNA when inside the cell – how will the mRNA be protected to avoid mutagenesis or breakdown?

To overcome these problems, companies such as Pfizer, BioNTech, and Moderna invested a lot of time, money, and effort into making mRNA vaccines effective. To facilitate transport of mRNA into the cell, common transfection reagents such as cationic lipids, calcium phosphate, and cationic polymer liposomes are used3 4. mRNA stability was achieved with the addition of untranslated regions (UTRs) added to the 5’ and 3’1 3

COVID-19 and Future Applications

On January 9, 2020, the Global Health Organization along with Chinese Health Authorities identified the novel coronavirus as 2019-nCoV (COVID-19)6. 2 days later, the Chinese government globally released the genomic sequence of the virus6. Pfizer, BioNTech, and Moderna were quick to start working on the vaccine. Only 11 months after COVID-19 was identified, the United States and United Kingdom established the latest mRNA vaccines as safe and effective1

Pfizer-BioNTech and Moderna mRNA vaccines code for a spike protein found on the membrane of the virus. Cellular uptake of the mRNA induces the production of a spike protein inside the host cell. The spike protein by itself is harmless and non-infectious but nonetheless, causes an immunological response that is remembered by the immune system. Pfizer-BioNTech and Moderna both require two doses of the vaccine, Pfizer-BioNTech requiring 21 days of separation, and Moderna requiring 28 days. Pfizer-BioNTech has a high effectiveness rate of 95% while Moderna is slightly lower at 94.1%.

Further applications for mRNA vaccines are contributing to the treatment of many more viral agents, among these are Ebola, Zika and Influenza. Cancer treatments, and genetic therapies are also looking at mRNA vaccines as a potential treatment to produce proteins that the body requires. 

Image result for covid 19 vaccines
Source: Aljazeera

References

  1. Pardy N, Hogan MJ, Porter FW, Weissman D. mRNA vaccines — a new era in vaccinology. Nat [Internet]. 2018 Jan 12 [cited 2021 Feb 12];17:261–279. Available from: https://www.nature.com/articles/nrd.2017.243
  2. Harvard Health Publishing: Why are mRNA vaccines so exciting? [Internet]. Komaroff A, editor. [cited 2021 Feb 12]. Available from: https://www.health.harvard.edu/blog/why-are-mrna-vaccines-so-exciting-2020121021599
  3. Kim TK, Eberwine JH. Mammalian cell transfection: the present and the future. Nat Lib Med [Internet]. 2010 Jun 13 [cited 2021 Feb 14];397:3173–3178. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2911531/
  4. Pfizer.com [Internet]. THE FACTS ABOUT PFIZER AND BIONTECH’S COVID-19 VACCINE. c2002 [cited 2021 Feb 13]. Available from: https://www.pfizer.com/news/hot-topics/the_facts_about_pfizer_and_biontech_s_covid_19_vaccine
  5. Huang J, Yang C, Xu XF, Xu W, Liu S. Structural and functional properties of SARS-CoV-2 spike protein: potential antivirus drug development for COVID-19. Nat [Internet]. 2020 Aug 3 [cited 2021 Feb 13];41:1141–1149. Available from: https://www.nature.com/articles/s41401-020-0485-4
  6. Whole genome of novel coronavirus, 2019-nCoV, sequenced. Sci Da [Internet]. 2020 Jan 31 [cited 2021 Feb 12]. Available from: https://www.sciencedaily.com/releases/2020/01/200131114748.htm
  7. Zhang C, Maruggi G, Shan H, Li J. Advances in mRNA Vaccines for Infectious Diseases. Front In Immu [Internet]. 2019 Mar 27 [cited 2021 Feb 12]. Available from: https://www.frontiersin.org/articles/10.3389/fimmu.2019.00594/full
Categories
COVID-19

A Closer Look at the Janssen Vaccine: How Effective is it?

Madison Norris — McMaster University Honours Life Sciences 2023


Over the last two years, the COVID-19 pandemic has completely changed the way in which we go about our everyday lives. The shift to online classes, working from home, social distancing restrictions and stay at home orders have left many yearning for a sense of normalcy. The only feasible solution to see us through the pandemic is the mass vaccination of the majority of the population.

Johnson and Johnson recently announced the completion of phase 3 clinical trials of the single dose Janssen vaccine. The Janssen vaccine contains viral DNA within a modified adenovirus that codes for the spike protein found on the surface of the SARS-CoV-2 virus. (1) Adenovirus-based vaccines use adenoviruses as vessels that will release genetic material upon entry into the cells of an inoculated host. The purpose of the vaccine is to protect against moderate to severe COVID-19 infections, including emerging variants of the virus, such as the B.1.351 variant proliferating in South Africa. (2)

In phase 3 clinical trials, 43,783 participants, 18 years of age or older, participated in a randomized double-blind study that compared the safety and efficacy of the Janssen vaccine to a placebo control. (2) The study population represented 8 different countries, including the United States, countries in Central and South America and South Africa. The study also included participants with comorbid conditions, such as obesity, type 2 diabetes, hypertension and immunocompromising conditions. (2) 28 days following vaccination, the Janssen vaccine demonstrated 66% efficacy. (2) However, it is important to note that differences in efficacy were found across geographical regions. The vaccine was observed to be most effective in the United States (72%) and less effective in Latin America (66%) and South Africa (57%). (2) In addition, the Jassen vaccine demonstrated similar rates of efficacy across age groups, including adults over the age of 60. The only side effect observed was a fever in approximately 9% of participants. As of March 5th, Health Canada has approved the Janssen vaccine.            

A notable difference between the Janssen vaccine and other competitor vaccines (Moderna and Pfizer) is that it can be stored for longer periods of time at refrigerator temperatures. To illustrate, the Janssen vaccine can be stored at 2°C to 8°C for 3 months, whereas the Moderna vaccine can only be stored at these temperatures for 30 days (3/4). Moreover, the Pfizer vaccine cannot be stored at refrigerator temperatures at all, and must remain in -60°C to -80°C conditions. (4) The ability to store the Janssen vaccine for longer periods of time at refrigerator temperatures presents the opportunity to transport vaccines to remote locations.

Another distinction of the Janssen vaccine is that while it has been observed to be less effective (66%) it only requires one dose. In contrast, both Moderna and Pfizer require two doses but are remarkably more effective at 94.1% and 95% efficacies, respectively. (5,6) This offers a potential solution to countries financially unable to fully vaccinate their citizens with a two dose vaccine. A more feasible alternative could be to vaccinate the elderly and at-risk populations with either the Pfizer or Moderna vaccines, as they are more susceptible and will experience more severe symptoms of the virus. The remaining population could then be vaccinated with the Janssen vaccine, as they have stronger immune systems that will allow for greater rates of recovery. (7)

In sum, the Janssen vaccine demonstrated an overall efficacy of 66%. The vaccine offers solutions to transportation, storage and financial barriers to vaccination. Following FDA approval, the administration of the Janssen vaccine brings the global population closer to herd immunity and one step closer to returning to normal life.

References

  1. Corum J. Zimmer C. How the Johnson & Jonson vaccine works. The New York Times. [Internet]. 2021 Feb 24 [cited 2021 Feb 24]; Health:[about 5 p.]. Available from: https://www.nytimes.com/interactive/2020/health/johnson-johnson-covid-19-vaccine.html.
  1. Janssen Vaccines & Prevention B.V. A randomized, double-blind, placebo-controlled phase 3 study to assess the efficacy and safety of Ad26.COV2.S for the prevention of SARS-CoV-2-mediated COVID-19 in adults 18 years and older. [Internet]. New Jersey: Janssen Vaccines & Prevention B.V; 2021 Jan 29 [cited 2021 Feb 24]. 184 p. Available from: https://www.jnj.com/johnson-johnson-announces-single-shot-janssen-covid-19-vaccine-candidate -met-primary-endpoints-in-interim-analysis-of-its-phase-3-ensemble-trial.
  1. CDC. Moderna COVID-19 vaccine: storage and handling summary. [internet] CDC; 2020 Dec 20 [cited 2021 Feb 24]. 2p. Available from: https://www.cdc.gov/vaccines/covid-19/info-by-product/moderna/downloads/storage-summary.pdf
  1. Pfizer Inc. Pfizer and Biotech submit COVID-19 vaccine stability data at standard freezer temperature to the U.S. FDA. New York: Pfizer Inc; 2021 Feb 19 [cited Feb 24]. P4. Available from:https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-submit-covid-19-vaccine-stability-data
  1. Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, et al. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. N Engl J Med. 2021; 384: 403-416. Available from: https://www.nejm.org/doi/full/10.1056/NEJMoa2035389
  1. Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, et al. Safety and efficacy of the BNT162b2 mRNA COVID-19 vaccine. N Engl J Med. 2020; 383: 2603-2615. Available from: https://www.nejm.org/doi/full/10.1056/NEJMoa203457
  1. CBC News. Johnson & Johnson single-shot COVID-19 vaccine appears 66% effective overall in global trial. The Associated Predd [internet]. 2021 Jan 29 [cited 2021 Feb 24]; Health: [about 1 p.]. Available from:https://www.cbc.ca/news/health/johnson-johnson-covid-vaccine-trial-1.5893009