The Long And Short Of Pfizer-BioNTech, Moderna, Sputnik V & Oxford-AstraZeneca Vaccines

Vaccination is an effective way to halt a pandemic. In the ongoing COVID-19 pandemic, the number of confirmed cases across the globe has crossed 60 million, with over 1.42 million fatalities, as of this writing. The U.S., which has reported 12.77 million cases and over 262,000 deaths, remains the worst-hit country.

As the country inches towards a full vaccine roll-out program for the public, let’s take a look at how some of the vaccines whose efficacy rates have been reported stack up.

1. BNT162b2

BNT162b2, developed by Pfizer Inc. (PFE) and BioNTech SE (BNTX), has demonstrated an efficacy of 95% in preventing COVID-19 in a phase III study.

The companies submitted a request to the FDA on November 20 for Emergency Use Authorization of BNT162b2 against SARS-CoV-2. Their request is scheduled to be reviewed by the FDA’s Vaccines and Related Biological Products Advisory Committee on Dec. 10.

Rolling submissions across the globe including in Australia, Canada, Europe, Japan and the U.K., have already been initiated.

Vaccine side effects:

No serious safety concerns were observed in the trial. The *Grade 3 adverse events including fatigue, headache, chills, muscle pain and joint paint were reported in younger participants. The older adults tended to report fewer and milder solicited adverse events following vaccination.

*Grade 3 events refer to severe or medically significant but not immediately life threatening.

Expected production:

The companies expect to produce globally up to 50 million vaccine doses of BNT162b2 in 2020 and up to 1.3 billion doses by the end of 2021.

Required storage conditions:

Pfizer has specially designed, temperature-controlled thermal shippers utilizing dry ice to maintain recommended temperature conditions of minus 70 degrees Celsius for up to 10 days. Ultra-low-temperature freezers, which are commercially available, can extend shelf life for up to six months. The vaccine can be stored for five days at refrigeration temperatures of 2 to 8 degrees Celsius.

Funds received:

U.S. government: $1.95 billion
German government: $445 million

Proposed price:

$19.50 per dose. BNT162b2 is a two-dose vaccine, given 28 days apart.

2. mRNA-1273

mRNA-1273, developed by Moderna Inc. (MRNA), has demonstrated an efficacy of 94.5% in preventing COVID-19 in a phase III study.

The company intends to submit for an Emergency Use Authorization with the FDA in the coming weeks. The European Medicines Agency’s human medicines committee (CHMP) has started a rolling review of the vaccine candidate.

Vaccine side effects:

The majority of adverse events related to mRNA-1273 were mild or moderate in severity. Grade 3 (severe) events included injection site pain, fatigue, myalgia, arthralgia, headache, pain and erythema/redness at the injection site.

Expected production:

By the end of 2020, Moderna expects to have approximately 20 million doses of mRNA-1273 ready to ship in the U.S. The company remains on track to manufacture 500 million to 1 billion doses globally in 2021.

Required storage conditions:

The vaccine can be stored at minus 20 degrees Celsius for six months, refrigeration temperatures of 2 to 8 degree Celsius for up to a week, and room temperatures conditions for up to 12 hours after thaw.

Funds received:

U.S. government: $2.48 billion

Proposed price:

$32 to $37 per dose. mRNA-1273 is a two-dose vaccine, given 28 days apart.

3. Sputnik V

Sputnik V, developed by Russia’s Gamaleya National Center of Epidemiology and Microbiology and Russian defense ministry, was approved by Russia’s Health Ministry on August 11, becoming the world’s first registered vaccine against COVID-19.

In clinical trials, the vaccine demonstrated an efficacy of 91.4% on day 28 after the first dose and 95% efficacy 42 days after the first dose, which also corresponds with 21 days after the second dose.

Vaccine side effects:

No unexpected adverse events were observed in the trials. Pain at the injection point and flu-like symptoms including fever, weakness, fatigue, and headache were experienced by a small number of participants in the trial.

Expected production:

There are agreements in place with international pharmaceutical companies that allow production of the vaccine abroad for 500 million people per year starting from 2021.

Required storage conditions:

Sputnik V has to be stored at minus 18 degree Celsius. The production of a lyophilized (dry) form of the vaccine that enables storage at a temperature of 2 to 8 degrees Celsius has been launched.

Proposed price:

Less than $10 per dose in international markets. Sputnik V is a two-dose vaccine, given 21 days apart.

4. AZD1222

AZD1222, also known as ChAdOx1 nCoV-2019, being developed by AstraZeneca plc (AZN) in collaboration with the University of Oxford, has demonstrated an average efficacy of 70.4% when phase III data from two dosing regimens were combined.

In a UK trial, where AZD1222 was given as a half dose, followed by a full dose at least one month apart, the efficacy was 90%. In a Brazilian trial where AZD1222 was administered as two full doses at least one month apart, the efficacy was 62%.

The one-and-a- half-dose regimen in the UK trial was given only by mistake, and it has produced a better efficacy than the two dose regimen.

In the UK trial, two adverse neurological events were reported – one, which was later diagnosed to be a case of multiple sclerosis and the other a case of transverse myelitis. The adverse events triggered a pause to vaccination across all global trials of AZD1222 vaccine in early September. However, following review by the respective regulatory authorities, which deemed the potential vaccine safe, the trials resumed in the United Kingdom, Brazil and South Africa by the end of September itself while the US trial resumed in October. Investigations later on revealed that the adverse events were linked to the participants’ pre-existing health conditions.

AZD1222 is under rolling review by the UK’s Medicines and Healthcare Products Regulatory Agency, and it could be granted emergency use authorization by mid-December.

Vaccine side effects:

No serious safety events related to the vaccine have been identified.

Expected production:

AstraZeneca expects to have 200 million doses ready worldwide by the end of 2020 and produce 3 billion doses of the vaccine in 2021.

Required storage conditions:

AZD1222 can be stored, transported and handled at normal refrigerated conditions of 2 to 8 degrees Celsius for at least six months and administered within existing healthcare settings.

Funds received:

U.S. government: $1.2 billion
UK Government: $80 million
Coalition for Epidemic Preparedness Innovations (CEPI) and Gavi: $750 million

Proposed price:

$3 per dose. AZD1222 is a two-dose vaccine, given 28 days apart.

Conclusion:

Including the above 4 COVID-19 vaccines, i.e., BNT162b2, mRNA-1273, Sputnik V and AZD1222, 48 candidate vaccines are in clinical evaluation and 164 are in preclinical stage.

It is important that everyone is vaccinated once a COVID-19 vaccine is available.

COVAX, coordinated by Gavi, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations (CEPI) and the World Health organization, is working for global equitable access to COVID-19 vaccines. More than $2 billion has been raised by the Gavi COVAX Advance Market Commitment to support equitable access to COVID vaccines this year with additional $5 billion needed in 2021.

Each country will have its own strategy on how the vaccines might be distributed. Generally, frontline healthcare system workers will be the first to receive a COVID-19 jab, followed by older adults and next will be the younger adults followed by children.

One of the main challenges in reaching the vaccines, especially, to people in regions with a warm climate is the limited cold-chain logistics infrastructure. But proper coordination between the global logistics companies, the respective governments and non-governmental organizations can solve the cold chain hurdles.

As pointed out by many health experts, vaccines don’t save lives but vaccinations do.

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