About a year after the outbreak of Coronavirus (COVID-19), the search to understand and curb the virus continues. In the line of this search, on Tuesday, December 31, 2020, the World Health Organisation (WHO) listed the Comirnaty COVID-19 mRNA vaccine for emergency use as part of its Emergency Use Listing (EUL). This makes the Pfizer/BioNTech vaccine the first to receive emergency validation from the WHO.
The WHO recommended this vaccine after regulatory experts, convened by the organisation from around the world, and WHO’s own teams reviewed data on the Pfizer-BioNTech vaccine’s safety, efficacy, and quality.
The vaccine is also under policy review as the WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) will convene on January 5, 2021, to formulate vaccine specific policies and recommendations for this product’s use in populations.
This policy formulation will be drawn from the SAGE population prioritization recommendations for COVID-19 vaccines issued in September 2020.
Before now, the Food and Drug Administration (FDA) of the United States of America on December 11, 2020, issued its first Emergency Use Authorization (EUA) to Pfizer/BioNTech vaccine for the prevention of COVID-19. Subsequently, on December 18, 2020, FDA issued its second EUA to the Moderna vaccine.
Similarly, the use of this Comirnaty vaccine was recommended for authorisation by the European Medicines Agency (EMA).
What is Comirnaty?
Comirnaty is COVID-19 mRNA vaccine. Comirnaty contains a molecule called messenger RNA (mRNA) with instructions for producing a protein from SARS-CoV-2, the virus that causes COVID-19. It is important to note that comirnaty does not contain the virus itself and cannot cause COVID-19.
This vaccine is produced by Pfizer and was named the Pfizer-BioNTech COVID-19 vaccine. However, the name comirnaty came when the vaccine was listed in the EU market.
The vaccine will be marketed in the EU under the brand name Comirnaty, which represents a combination of the terms COVID-19, mRNA, community and immunity, to highlight the first authorization of a messenger RNA (mRNA) vaccine, as well as the joint global efforts that made this achievement possible.
The WHO’s Emergency Use Listing (EUL) opens the door for countries to expedite their own regulatory approval processes to import and administer the vaccine.
This also enables UNICEF and the Pan-American Health Organization to procure the vaccine for distribution to countries in need.
What is the WHO EUL and how does it work?
The emergency use listing (EUL) of the WHO is a procedure that assesses the suitability of novel health products during public health emergencies like that of the COVID-19 pandemic.
The aim of this is to make medicines, vaccines and diagnostics available as rapidly as possible to address the emergency while adhering to stringent criteria of safety, efficacy and quality. This assessment weighs the threat posed by the emergency as well as the benefit that would accrue from the use of the product against any potential risks.
The EUL pathway involves a rigorous assessment of late phase II and phase III clinical trial data as well as substantial additional data on safety, efficacy, quality and a risk management plan. These data are reviewed by independent experts and teams of the WHO who consider the current body of evidence on any vaccine under consideration, the plans for monitoring its use, and plans for further studies.
Once a vaccine has been listed for WHO emergency use, WHO engages its regional regulatory networks and partners to inform national health authorities on the vaccine and its anticipated benefits based on data from clinical studies to date.
Outside the global, regional, and country regulatory procedures for emergency use, each country undertakes a policy process to decide the use of the vaccine, with prioritization specified for the earliest use. Countries also undertake a vaccine readiness assessment which informs the vaccine deployment and introduction plan for the implementation of the vaccine under the EUL.
As part of the EUL process, the company producing the vaccine must commit to continue to generate data to enable full licensure and WHO prequalification of the vaccine.
Subsequently, the WHO prequalification process will assess additional clinical data generated from vaccine trials and deployment on a rolling basis to ensure the vaccine meet the necessary standards of quality, safety, and efficacy for broader availability and use.
Countries where the vaccine is in use.
The Pfizer vaccine has already been approved in 46 countries.
The United Kingdom (UK)
Early in December 2020, the United Kingdom (UK) approved the Pfizer vaccine for roll out, making it the first Western country to license a vaccine against COVID-19, expecting 800,000 doses.
The vaccine was authorised for emergency use by the Medicines and Healthcare products Regulatory Authority (MHRA).
Bahrain
On December 4, Bahrain approved the emergency use of Pfizer COVID-19 vaccine. Thus was made by Bahrain’s National Health Regulatory Authority (NHRA).
This made it the second country in the World to approve the vaccine after the UK.
Although Bahrain did not state the number of vaccines purchased, one thing that might be a challenge for the country is how to store the vaccine under the recommended ultra-cold temperatures of approximately minus 70 degrees Celsius (minus 94 degrees Fahrenheit).
This is because Bahrain is a Middle East nation that regularly sees temperatures in the summer of about 40 degrees Celsius (104 degrees Fahrenheit) with high humidity.
Canada
Canada also on December 9, 2020, approved Pfizer vaccine the day after the UK rolled out the vaccine.
The Canadian government purchased 20 million doses of the vaccine which was said to be enough to inoculate 10 million people.
Canadian officials say Canada has 14 distribution sites equipped with the necessary cold storage for the vaccine.
The United State (US)
The United State of America’s Food and Drug Administration also authorised the Pfizer-BioNTech coronavirus vaccine for emergency use
Mexico
Mexico become the fourth country to approve the emergency use of the Pfizer-BioNTech COVID-19 vaccine on
The Mexican government said it would begin a vaccination drive against the coronavirus by the end of December after ordering the first batch of 250,000 doses to immunise 125,000 people.
Chile
The Chilean health regulator also approved for emergency use the COVID-19 vaccine from Pfizer Inc.
Singapore
Singapore approved the Pfizer vaccine while awaiting its first shipment by the end of December.
Saudi Arabia
Saudi Arabia approved an inoculation by Pfizer and its German Partner BioMTech to fight COVID-19.
Kuwait
Kuwait also authorised the use of Pfizer vaccine.
Costa Rica
The health ministry of Costa Rica announced the authorisation of Pfizer vaccine for use.
Ecuador
Ecuador’s National Agency for Regulation, Control and Sanitary Vigilance (ARCSA) approved the use of Pfizer vaccine.
Panama
Panama approved the emergency use of Pfizer vaccine. The first batch of the shot would be available in the first quarter 2021.
Switzerland
Switzerland approved the Pfizer vaccine for use as its first vaccine against COVID-19. Switzerland ordered for three million vaccine doses.
Israel
Israel also approved the Pfizer vaccine. Its administration will be at a rate of 150,000 people a day which amounts to almost 2% of the population.
Argentina
Argentina also approved the Pfizer vaccine for use after approving the Russian Sputnik V.
Colombia
Colombia makes a deal with Pfizer Inc. to get supplies of its COVID-19 vaccine in the first half of 2021. The country said it has plans on transporting and storing the vaccine.
European Union (EU) Countries
Following the European Union (EU) approval of the Pfizer Vaccine, which was promoted by the European Medicine Agency’s (EMA) recommendation for the vaccine, the 27 countries under the EU have approved or commenced vaccination with the Pfizer vaccine.
The 27 countries are: Hungary, Slovakia, Italy, Austria, Germany, Spain, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, Greece, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Romania, Slovenia, Sweden, Portugal, ireland, and France.
The EMA recommendation also allows Iceland, Liechtenstein and Norway to get access to vaccinations.
Other approved vaccines.
There are currently more than 50 COVID-19 vaccine candidates in trials on the WHO landscape for candidate vaccines.
According to COVID-19 vaccine tracker, there are 73 vaccines with 23 in phase one, 32 in phase two, 18 in phase three, and five approved by at least one country or more.
The five vaccines include: the Moderna Vaccine authorized in the US and Canada, sinopharm BBIPB-CorV in China, United Emirates and Bahrain, Gamaleya Sputnik V in Russia, Belarus and Argentina, and Oxford-AstraZeneca in the UK.
As of December 28, 2020, large-scale (Phase 3) clinical trials are in progress for AstraZeneca’s COVID-19 vaccine, Janssen’s COVID-19 vaccine, and Novavax’s COVID-19 vaccine in the United States.
This is the booster why is it saying you need 2 injections 3 weeks apart?