What is the current status of COVID-19 Vaccine development & approval?
Sai Krishna Muthyanolla
May 18, 2021
Many countries across the world have rolled out COVID-19 vaccination to its citizens. Vaccines have received emergency use approval from multiple countries. Here is a review of the COVID-19 currently being administered around the world.
Within a year of the emergence of COVID-19, vaccines have been developed, approved, and administered to people in various parts of the world. Resources were diverted towards the development of vaccines and countries were in a race to develop and procure vaccines to curb the spread of the pandemic. Usually, it takes years of research and testing before the vaccines are tried on human beings. But the quick spread of the COVID-19 pandemic across the world left no choice but to accelerate the development, trial, and production of vaccines, in record time. As of 15 May 2021, 1.45 billion doses of vaccines have been administered across the world. According to WHO’s draft landscape of novel coronavirus candidate vaccine development worldwide, 100 vaccines were in clinical development and 184 vaccines were in pre-clinical development stages on 14 May 2021.
14 Vaccines have been approved/authorized globally
Globally, fourteen vaccines have been granted emergency use authorizations or have been approved by national regulatory authorities in various countries, according to the New York Times Vaccine Tracker. These 14 vaccines are listed below. Besides, there are 27 vaccine candidates undergoing phase-3 trials, 37 in phase-2, and 49 vaccine candidates in phase-1 trials.
This is the most widely approved & used vaccine which has been given full approval for usage in Brazil and provisional approval for two years in Australia. More than 60 countries including India, UK, European Union, Canada, Saudi Arabia, Bahrain, etc. have given emergency use authorization for the vaccine. It also received  Emergency use validation from the WHO. However, Denmark, Norway and Iceland temporarily suspended the rollout of the AstraZeneca vaccine while Italy and Austria stopped using certain batches of the drug as a precautionary measure when cases of blood clots in persons who were given this vaccine were reported. The company has increased its manufacturing capacity for up to 3 billion doses in 2021.
The vaccine has been approved by Saudi Arabia, Switzerland, Bahrain, and has been given provisional approval in Australia. Emergency use authorization for the vaccine has been granted in nearly 50 countries including the US for those aged 16 and above. It is also approved for emergency use in European Union, UK, Singapore, Japan, New Zealand, etc. WHO too has granted emergency use approval for this vaccine. The vaccine is currently in trials for usage on pregnant women. It is expected that 3 billion doses of this vaccine will be produced in 2021.
Sputnik V, which is the first registered vaccine against COVID-19, according to the website, was given approval in Russia as early as August 2020. It has been given authorization for emergency use in nearly 60 countries including India, UAE, Argentina, Kazakhstan,  Mexico, etc. Mainly, the countries in Asia, Africa, and South America have approved the vaccine. Russia has also introduced Sputnik Light vaccine which requires only a single dose.
The vaccine was given approval by the Swiss authority in January 2021, following the qualification of strict requirements for safety, efficacy, and quality. European Union, Canada, Singapore, UK, WHO, and the US have granted emergency use authorization. Only about 15 countries have given authorization for the vaccine. The vaccine is being tested for babies and young children. Moderna made an announcement in April 2021 that they would produce 800 million to 1 billion doses in 2021 and planned to manufacture 3 billion doses in 2022.
Bahrain was the first country to authorize the vaccine for emergency use in 2021. Later, the US, European Union, Canada, South Africa, South Korea, WHO, and others approved it for emergency use. However, due to clots formation in some persons who took the vaccine, Denmark discontinued using it. Even the US has temporarily stopped its usage. The company is conducting trials of the vaccine on pregnant women and will soon be conducting trials on children. The company is aiming for the production of a billion doses in 2021.
The vaccine, developed by Bharath Biotech in India in collaboration with ICMR, has been given emergency use authorization in India, Mexico, Zimbabwe, Botswana, Nepal, etc. (around 12 countries). It is expected that vaccine production will be increased to 700 million doses a year. The vaccine is currently under phase 2/3 trial for children aged 2 to 18 years.
The one-shot vaccine was approved in China in February 2021. Trials were carried in countries like Pakistan, Chile, Russia, and Mexico.
Only Turkmenistan has approved the vaccine, as per reports, and Russia has included it in its mass vaccination drive.
China and Uzbekistan have given emergency approval for this vaccine.
The vaccine has been approved for use in China, Bahrain, and UAE. Around 20 countries have given authorization for emergency usage, besides WHO.
While only China has given approval for the vaccine, around 20 other countries such as Brazil, Mexico, Malaysia, etc. have given emergency authorization for the same. The vaccine is under second phase trial for usage among children and adolescents. The company announced that it will produce up to 2 Billion doses annually.
Developed by the Wuhan Institute of Biological Products, the vaccine has been approved only in China.
The vaccine is currently being administered only in Kazakhstan, in 2 doses.
The vaccine has been registered and used under early use only in Russia.
Only Six Vaccines approved by WHO recognized Stringent Regulatory Authority
It is observed that only six of these vaccines have been approved for emergency or full use by at least one WHO-recognized stringent regulatory authority, Oxford–AstraZeneca, Pfizer-BioNTech, Sputnik V, Sinopharm-BBIBP, Moderna, and Johnson & Johnson. In terms of absolute numbers, most of the approved vaccines have been developed by Russia and China. Furthermore, it is seen that the distribution of vaccines is not equitable. Only a few countries, predominantly the rich ones, have placed orders and given approvals proactively. Though there are initiatives like COVAX, equitable vaccine distribution is a big issue.
India is trying to make approvals faster amidst vaccine shortage concerns
Meanwhile in India, India’s drug regulator, the Central Drugs Standards Control Organisation (CDSCO), has decided to speed up the vaccine approval process in the country. For vaccines not yet approved or licensed in India but are approved in the US, Europe & by WHO, the CDSCO will give permission for restricted use in the country provided the following three conditions are met- the vaccine use should be as per guidelines prescribed under National COVID-19 Vaccination Programme, the first 100 beneficiaries of the vaccine should be assessed for a week for safety outcomes before it is rolled out, and the applicant should conduct post-approval bridging clinical trials within 30 days of approval.
The government has also accepted the COVID-19 National Task Force’s recommendation to authorize foreign-produced COVID-19 vaccines which have been granted emergency approval by the US, UK, EU, Japan and WHO-listed agencies. This comes at a time when states have complained of vaccine shortages.
Other vaccines under trials in India
There are other vaccine candidates under trial in India, besides Covishield and Covaxin that are currently being administered. These are- ZyCoV-D by Zydus Cadilla which is currently under phase 3 clinical trials, Biological E’s novel COVID-19 vaccine which is under Phase 1/2 clinical trials, BBV154 – Intranasal vaccine by Bharath BioTech under Phase 1 human trial, Covovax under phase 2/3 trial, and mRNA based vaccine (HGCO19) under phase 1/2 trial.
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