Summary
- The entire world has its eyes set on vaccine-developing companies, but some major vaccine manufacturing institutions are playing an equally important role in the fight against the pandemic.
- So far, COVID-19 vaccine developed by Pfizer/BioNTech, AstraZeneca/Oxford, and Moderna have obtained regulatory approvals.
- Johnson & Johnson has also applied for FDA approval for Janssen’s COVID-19 vaccine.
- Novavax’s COVID-19 vaccine rolling review has been initiated by the FDA, Health Canada, MHRA, and EMA.
Vaccine development typically requires years of research, testing and additional time for large-scale manufacturing. However, this time researchers across the globe raced against the clock to develop anti-coronavirus vaccines within a year amid the pressing need for a solution. With several vaccines receiving regulatory approval, the challenge now is to manufacture and distribute billions of vaccine doses.
While the world is counting on pharmaceutical/biotech giants to achieve this task, Serum Institute of India (SII), which is the world’s largest vaccine manufacturer, has played a massive role in the manufacturing and distribution of millions of vaccine shots across the globe.
Source: Copyright © 2020 Kalkine Media Pty Ltd.
The United Nations International Children's Emergency Fund (UNICEF) and the Serum Institute of India have signed a supply agreement for COVID-19 vaccines manufactured by AstraZeneca/Oxford and Novavax. With the deal, the UNICEF will have access to up to 1.1 billion doses of vaccines for almost 100 nations worldwide. With this agreement, Oxford-AstraZeneca’s vaccine and the Novavax vaccine would be produced by Serum Institute of India and US-based Novavax Inc., respectively.
UNICEF plays a significant role in immunization campaigns worldwide. The organization has applauded the development, describing COVAX as the biggest vaccine procurement and supply operation ever launched.
Let us have a look at the companies developing COVID-19 vaccines-
Pfizer and BioNTech
As per Pfizer Inc (Nasdaq:PFE) and BioNTech (Nasdaq:BNTX), their vaccine candidate BNT162b2 met Phase 3 study’s primary efficacy endpoints in November 2020. Analysis of the data indicated an efficacy rate of 95% for COVID-19 prevention.
Recently, Pfizer and BioNTech entered an agreement with the COVAX Facility for 40 million doses of their vaccine, COMIRNATY®. The Companies stated that doses would be delivered throughout 2021.
In January 2021, Pfizer and BioNTech got another shot in the arm as their vaccine candidate was also found to demonstrate protective activity against the new variants of the SARS-CoV-2 virus and is easily adaptable.
Earlier, the vaccine ticked off major boxes in December:
- On 2 December 2020, UK regulator Medicines & Healthcare Products Regulatory Agency (MHRA) granted a temporary authorization for emergency use of BNT162b2.
- On 11 December 2020, Pfizer and BioNTech received the FDA nod for the emergency use of BNT162b2 against COVID-19 in individuals 16 years of age or older.
- On 21 December 2020, the companies disclosed that the EC had granted a conditional marketing authorization (CMA) to Pfizer and BioNTech for BNT162b2 for active immunization.
On 12 February 2021, PFE shares last traded at US$34.72, up 0.84%.
Source: Copyright © 2020 Kalkine Media Pty Ltd
Moderna Inc
Moderna Inc (Nasdaq:MRNA) is pleased to be one of the many groups working to respond to the ongoing global health emergency. Moderna’s COVID-19 vaccine mRNA-1273 was found to be 94% effective against the coronavirus.
Recently, the Company updated that the US government had purchased an additional 100 million doses of Moderna’s COVID-19 vaccine, bringing its confirmed order commitment to 300 million doses. Moderna anticipates delivering extra doses before the end of July 2021. So far, the Company has supplied more than 41 million doses to the US government.
Moderna has confirmed supply agreements with several countries to provide more than 631.5 million doses of mRNA-1273.
On 12 February 2021, MRNA shares last traded at US$183.74, up by 0.16%.
AstraZeneca and Oxford University
British pharmaceutical behemoth AstraZeneca Plc (LON:AZN) has been working with Oxford University researchers to develop its COVID-19 vaccine. AstraZeneca has signed several distribution agreements across multiple jurisdictions to provide its COVID-19 vaccine.
One of the major advantages the AstraZeneca/Oxford COVID-19 vaccine has over other candidates is that it can be stored, handled, and transported at normal refrigerated conditions (i.e., 2-8°C or 36-46°F) for a minimum period of six months.
AZN disclosed that the Company continues to engage with international organizations, governments, as well as collaborators worldwide. This way, the Company ensures wide and equitable access to the vaccine without any profit for the duration of COVID-19 pandemic.
Johnson & Johnson
Johnson & Johnson’s (NYSE:JNJ) Janssen Biotech Inc is developing its COVID-19 vaccine by using AdVac® vaccine platform.
On 4 February 2021, Johnson & Johnson updated that it has submitted the emergency use authorization (EUA) to the FDA based on top-line efficacy and safety information from the Phase 3 ENSEMBLE clinical trial. The trial data demonstrated that the vaccine was ~66% effective in protecting against coronavirus.
Source: © Akakshu | Megapixl.com
Janssen’s investigational single-dose COVID-19 vaccine is estimated to remain stable for two years at -4°F (-20°C), out of which, for three months at least, it can be stored in most standard refrigerators at temperatures of 36°F-46°F (2°-8°C).
On 12 February 2021, JNJ shares last traded at US$166.58, up by 0.31%.
DO READ: US to get 3rd COVID-19 vaccine, Johnson & Johnson files Emergency Use Authorization
Novavax Inc
American vaccine development company Novavax Inc (Nasdaq:NVAX) is developing a protein-based COVID-19 vaccine candidate NVX-CoV2373, which was developed using the recombinant nanoparticle technology of Novavax.
On 4 January 2021, the Company updated the market that rolling review of its COVID-19 vaccine was initiated by the FDA, Health Canada, MHRA, and EMA. Novavax also stated that the regulatory reviews would continue as the Company completes its pivotal Phase 3 clinical trials in the UK and US through the initial authorization for emergency use granted under country-specific regulations.
According to some media reports, the European Union (EU) could sign a deal with Novavax for COVID-19 vaccine supply in the coming weeks.
On 12 February 2021, NVAX shares last traded at US$289.76 down by 2.85%.