COVID-19 VACCINES ON THE HORIZON-CLINICAL TRIALS

The latest report says, the first COVID-19 vaccine approval from Health Canada could come before Christmas with most Canadians expected to be vaccinated by September 2021. Eagerly and anxiously, we all have waited for this announcement with bated breath since long. But feds warn of logistical challenges. The Government of Canada is assertively pursuing the purchase and development of COVID-19 vaccines and related supplies to protect Canadians by engaging with international and domestic scientists and with businesses and manufacturers. Unfortunately, as Canada no longer has any domestic production capacity for vaccines, the Government is negotiating and signing agreements with a number of leading pharmaceutical companies to establish a guaranteed supply base of potential vaccine.

Canada has signed contracts for more doses per capita than any country in the world with expectation of their arrival in the next few months. That involves buying 126 freezers, including 26 ultracold ones, to hold millions of doses of vaccines. Two Covid-19 vaccines have been found to be highly effective in late-stage trials in recent days, boosting optimism at a time when health systems in Europe and the U.S. are once again in jeopardy. American pharmaceutical firm Pfizer and Biotechnology company Moderna are the first companies to release partial results from Phase 3 clinical trials in the race to develop a vaccine against the deadly SARS-CoV-3 virus that causes COVID-19.

PSPC (Public Services and Procurement Canada) is also procuring the equipment and supplies that will be needed to perform the final manufacturing and packaging stages of vaccine production in Canada, as well as the materials needed to support safe, efficient immunization such as syringes, needles, alcohol swabs and other supplies. There is an expected investment of up to $56 million to support clinical trials for a COVID-related vaccine which is funded from the Government’s $600 million to support COVID-19–related vaccine and therapy clinical trials led by the private sector and to support Canadian bio-manufacturing opportunities. Other projects are still under consideration.

Health Canada has started work on approving at least three vaccines. Investors have treated vaccine development as a race between companies, although there is likely to be global demand for as much vaccine as can be produced for the foreseeable future. Authorization of vaccines for children will take longer. Pfizer has started vaccinating volunteers under the age of 18 in trials, giving shots to children as young as 12. Moderna and Johnson & Johnson have said they hope to start testing the vaccine in younger patients soon. As per the reports, Moderna plans to ask the U.S. Food and Drug Administration for an emergency use authorization for its vaccine in the coming weeks.

Traditional vaccine versus mRNA vaccine

Traditional vaccines are made up of small or inactivated doses of the disease-causing organism, or the proteins that it produces, which are introduced into body to provoke the immune system into growing a response. mRNA vaccines, in contrast, trick the body into producing some of the viral proteins itself. Pfizer and Moderna vaccines contain messenger RNA and they are expected to have better effects than traditional vaccines. mRNA vaccines do not contain a live virus and do not carry a risk of causing disease in the vaccinated person. With the Pfizer and Moderna vaccines, messenger RNA is injected into the body, where it enters the cells and provides instructions to make antigens. When the cell presents the antigens to the body’s immune system, that triggers the production of T-cells and antibodies to fight the infection. Recent improvements in mRNA vaccines believed to increase protein translation, modulate innate and adaptive immunogenicity, and improve delivery.

Vaccines: Names, status, and updates

Pfizer/BioNtech: Status: Ends trial with 95% efficacy - approval pending. Phase 3 trials in the United States showed up to 95-per-cent effectiveness.

Moderna: Status: Interim Phase 3 results show greater than 90% efficacy – approval pending. Phase 3 trials in the United States showed up to 95-per-cent effectiveness.

AstraZeneca/Oxford: Status: Phase 3 in progress. Late-stage trials in Britain and Brazil showed 62- to 90-per-cent effectiveness based on the dosage and combination of doses.

Medicago/GSK: Status: Phase 2/3 trials in progress. Phase 2 / 3 trial launched Nov. 12 in U.S. and Canada.

NovaVax: Status: Phase 3 trials in progress

Janssen/Johnson & Johnson: Status: Phase 3 trials in progress

Sanofi/GSK: Status: Awaiting Phase 3 trials. Phase 3 anticipated to begin in late 2020 or early 2021

Overview of the vaccines Canada planning to buy

PFIZER & MODERNA

Canada is among the countries that moved quickly to make deals for some of the leading vaccine candidates, based on recommendations from a federally appointed task force. Canada has a lock on 20 million doses of vaccine produced jointly by Pfizer Inc. and Germany’s BioNtech., which was the first to pass through a Phase 3 clinical trial with data showing it to be 95 % effective. Canada has also ordered up to 56 million doses of Moderna’s vaccine (equally strong interim results, produced by Moderna in Cambridge, Mass.). The two orders combined are believed to be enough to vaccinate every Canadian with required two doses.

The success rate of the vaccine developed by Pfizer and BioNTech is the highest of any candidate in late-stage clinical trials so far, and experts are very hopeful. Both vaccines are developed with new messenger RNA (mRNA) technology, have raised hopes for an end to a pandemic.

Challenges

Problems could arise with Pfizer and Moderna’s drugs as more data come in.
Both rely on a new technology.
Unlike traditional vaccines, which work by delivering a weakened virus or viral proteins to help train body’s immune system, both these vaccines consist of tiny particles that carry genetic instructions in the form of RNA, which body takes up and uses to generate copies of viral proteins.

ASTRAZENECA

On Nov.23, the U.K.-based pharmaceutical company AstraZeneca announced that its vaccine developed in partnership with Oxford University, is also showing good efficacy based on interim results from a multinational Phase 3 trial. This two-dose vaccine was 62% effective initially but found 90 % effective later. Scientists are awaiting complete results from the trials.

Distributing Shots

Pfizer says it expects to make around 50 million vaccine doses this year, enough to protect 25 million people, followed by 1.3 billion doses in 2021. Pfizer has agreements with European Union, Germany and Japan where distribution may begin next year.

Advantages

The Pfizer-BioNTech shot was found to have 94 % efficacy in people over 65 years, which experts said was crucial at a time when COVID-19 is widespread with record numbers of new cases and hospitalizations.
Pfizer said its two-dose vaccine, called BNT162b2, was well-tolerated and that side effects were mostly mild to moderate, and cleared up quickly.
Only Pfizer has started vaccinating volunteers under the age of 18 in trials, giving shots to children as young as 12.

Flip side

This vaccine requires a storage temperature of minus 94º F and requires special storage equipment and transportation. This may make it difficult for some countries to distribute.
If the vaccines are stored in glass vials, the glass should withstand such Arctic temperatures.
Facilities in rural areas may not have the very expensive freezers that can store the Pfizer vaccine at such a low temperature.
Similar problems may be encountered if the vaccine is given to people at pharmacies and doctor's offices, as opposed to larger medical centers.
Some states, cities and hospitals are rushing to purchase ultra-cold freezers, which is extremely expensive. Also, the freezer manufacturers are warning of long wait times. Pfizer is reportedly charging $20 per dose for its vaccine.
Distribution of a Pfizer-BioNTech shot is complicated by the need to store it at ultracold temperatures of –70C. It can, however, be kept in a normal fridge for up to five days, or up to 15 days in a thermal shipping box. But, the vaccine contains genetic material-mRNA that may degrade at room temperature.

Oxford-AstraZeneca vaccine

Advantages

An interim analysis of clinical trials showed the Oxford-AstraZeneca vaccine had an average efficacy of 70% in protecting against the virus.
AstraZeneca’s vaccine appears to have an advantage when it comes to storage, affordability and distribution since it can be stored, transported and handled at normal refrigerated conditions (36-46˚ F) for at least six months and administered within existing health-care settings.
It has been found to be “highly” protective, potentially paving the way for a vaccine that is more affordable and easier to distribute than some of its peers.
As per reports, Oxford-AstraZeneca vaccine, which requires two doses, is priced at approximately $3 to $4 — significantly lower than the prices reported for Pfizer-BioNTech and Moderna.
As per the reports, emerging markets such as Brazil, Mexico, India and Indonesia, are likely to be the “big beneficiaries” of this vaccine due to cheaper cost of production and distribution.
AstraZeneca has said it is making rapid progress in terms of manufacturing, with a capacity to produce up to 3 billion doses of the vaccine next year.

Flip side

The overall results show the vaccine’s efficacy is slightly lower than other leading candidates.

Moderna

Advantages

As per reports, this vaccine was found to be 94.5% effective in initial results.
It does not have the same requirement for storage at ultra-cold temperatures like Pfizer.
It can be kept at regular room temperature for up to 12 hours. It can also remain stable at the temperature of a standard home refrigerator for up to 30 days. It can also be stored for up to six months at minus 4 degrees Fahrenheit.
Moderna’s vaccine can be stored in a regular refrigerator. The ability to store the vaccine in a regular freezer would be a boon for distribution of the vaccine. Hence, it is easier to store, transport, and prepare than Pfizer's.
It does not require dilution or special handling at health care facilities. Hence, administering this vaccine in pharmacies and physician offices can be fairly easy.

Huge challenges remain before a vaccine can be rolled out to combat the Covid-19 pandemic. The global battle to secure prospective supplies has raised concerns about fair access, while questions remain over the management of mass production, distribution, and cost factors. The reports also express the concern about the timing of vaccine launch and the change in administration in the U.S since the administration need to engage in ensuring seamless transition and proper distribution of the vaccine earliest possible.

With vaccine makers poised to request authorization for their shots, and officials preparing to tackle legal and management obstacles, take-home message for the general public should be to continue wearing masks, physically distance, wash hands frequently, and avoid large gatherings until a high proportion of the population is vaccinated and we can finally emerge into a Covid-19 free world!

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References:

1. Canada.ca/Govt. of Canada/news