COVID-19 Vaccines – The Blues And Ease Of Cold Storage
(RTTNews) – The tally of COVID-19 cases has crossed the 54 million mark globally, with fatalities of over 1.31 million, according to the Johns Hopkins University. With over 11 million cases and more than 246,000 fatalities, the U.S. remains the worst-hit country by the pandemic.
An effective coronavirus vaccine is one good way to put an end to the pandemic. According to the World Health Organization, 48 vaccines targeting the SARS-CoV-2 virus are in clinical evaluation and 168 are in preclinical stage.
Vaccines must be stored properly from the time they are manufactured until they are administered. Proper storage and handling of the vaccines by maintaining the cold chain will go a long way in assuring the potency and efficacy of a vaccine. A proper cold chain is a temperature-controlled supply chain that includes all equipment and procedures used in the transport and storage and handling of vaccines from the time of manufacture to administration of the vaccine. (Source: CDC).
In this article, you will find a few stocks listed on the U.S. stock exchanges that merit attention as the companies continue to make progress with their COVID-19 shots.
1. BNT162b2 by Pfizer/BioNTech
BioNTech SE (BNTX) is developing a COVID-19 vaccine BNT162b2, in collaboration with Pfizer Inc (PFE). This vaccine candidate is under a phase III study – the pivotal, last stage on which the approval is based.
BNT162b2 is based on BioNTech’s proprietary mRNA technology and supported by Pfizer’s global vaccine development and manufacturing capabilities. This vaccine is being tested at a 30 micrograms (mcg) dose level in a two-dose regimen, given 21 days apart.
In the first interim efficacy analysis of the phase III trial, conducted on November 8, 2020 by an external, independent Data Monitoring Committee, BNT162b2 has been found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection.
The safety data of the vaccine is expected to be available by the third week of November after which the companies plan to seek Emergency Use Authorization from the FDA.
The European Medicines Agency and Health Canada have already begun rolling review of BNT162b2.
Pfizer and BioNTech have agreed to supply 200 million doses of BNT162b2 mRNA-based vaccine candidate against SARS-CoV-2 to European Union (EU) Member States, with an option for the European Commission to request an additional 100 million doses. If approved, the companies expect to start delivery of the vaccine to the European Union by the end of this year.
The companies expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021.
BNT162b2 is said to be stable only when it is stored at minus 70 degrees Celsius or below. So, the ultra-low temperature storage may pose a significant challenge for the transport and distribution of Pfizer/BioNTech’s COVID-19 shot.
2. mRNA-1273 by Moderna
Moderna Inc.’s (MRNA) COVID-19 vaccine candidate mRNA-1273 is under a phase III study.
mRNA-1273 is a lipid nanoparticle (LNP)-encapsulated mRNA-based vaccine, and in the phase III trial, dubbed COVE, the vaccine is being tested at a 100 mcg dose level in a two-dose regimen, given about 28 days apart.
The first interim analysis of the COVE study is expected this month, and in order for mRNA-1273 to be a success, it needs to demonstrate an efficacy of 74% or greater, according to the company. The safety data is expected to be available in the second half of this month.
The company plans to seek emergency nod from the FDA for mRNA-1273 upon positive efficacy and 2-month median safety data.
Moderna has initiated rolling submissions for mRNA-1273 in the U.K. and Canada. Swissmedic has started a rolling review of the vaccine candidate.
The storage conditions of mRNA-1273 are not as challenging as Pfizer/BioNTech’s BNT162b2 as it can be stored at minus 20 degrees Celsius.
Moderna believes it can produce about 20 million doses of mRNA-1273 in 2020 and from 500 million up to one billion doses worldwide in 2021.
3. AZD1222 by AstraZeneca
AstraZeneca PLC’s (AZN) Covid-19 vaccine, AZD1222, licensed from the Oxford University, is a recombinant adenovirus vaccine and is under phase III testing.
In the phase III trial, the vaccine is being tested at a dose of 5 × 10^10 viral particles in a two-dose regimen, given about 28 days apart.
The pivotal trial was put on hold in early September after 1 case of serious adverse reaction was reported in a participant in the U.K. However, the trials have now resumed across the world. Results from the late-stage trials are anticipated later this year.
AZD1222 can be stored at normal refrigeration temperatures of 2 to 8 degrees Celsius.
4. Ad26.COV2.S by Johnson & Johnson
Johnson & Johnson’s (JNJ) COVID-19 vaccine Ad26.COV2.S is an adenovirus serotype 26 (Ad26) vector-based vaccine that is under a phase III trial, dubbed ENSEMBLE.
The trial, initiated in late September, was temporarily paused after a study participant developed an unexplained illness. However, the trial resumed late October after an independent Data Safety Monitoring Board, which conducted a thorough evaluation, deemed it safe to do so.
In the ENSEMBLE trial, Ad26.COV2.S is being tested at a dose level of 5 × 10^10 viral particles as a single dose vaccine. Initial readout from the trial is expected early next year.
Ad26.COV2.S can be stored at normal refrigeration temperatures of 2 to 8 degrees Celsius for at least three months and it can remain stable for two years when stored at minus 20 degrees Celsius.
5. NVX-CoV2373 by Novavax
Novavax Inc’s (NVAX) COVID-19 vaccine candidate NVX-CoV2373 is under a phase III trial in the U.K.
NVX-CoV2373 is a stable, purified SARS-CoV-2 spike (S) glycoprotein made using the company’s recombinant protein nanoparticle technology that includes proprietary MatrixM adjuvant.
In the phase III trial, NVX-CoV2373 is being tested at 5 mcg dose with 50 mcg Matrix-M adjuvant in a two-dose regimen, administered 21 days apart. Interim data from the phase III UK trial are expected as soon as early first quarter 2021.
Novavax expects to begin its pivotal phase III trial of NVX-CoV2373 in the United States and Mexico by the end of November.
The transport, storage and handling of NVX-CoV2373 could be less challenging as the vaccine is stable at normal refrigeration temperature of 2 to 8 degrees Celsius.
6. CVnCoV by CureVac
CureVac N.V.’s (CVAC) COVID-19 vaccine candidate CVnCoV is an mRNA-based vaccine that is under a phase IIa clinical trial in Peru and Panama.
The company plans to initiate a pivotal phase IIb/III clinical study of CVnCoV by the end of this year. This trial will test 12 mcg of CVnCoV in a two-dose regimen, given 28 days apart.
CVnCoV has the potential to fulfill standard vaccine cold chain requirements, as it is said to remain stable for at least 3 months when stored at 5 degrees Celsius and up to 24 hours as ready-to-use vaccine when stored at room temperature.
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