The COVID-19 outbreak has shaken the global health system and economy by its roots. This epidemic is continuously spreading and showing no signs of slowing down. Vaccination could be the only effective and economical means to control or stop this pandemic. Many research institutions and pharmaceutical companies worldwide are currently involved in the development of a suitable coronavirus vaccine.
What are the Stages of development for a covid 19 Vaccine?
The development of coronavirus vaccines consists of the following steps e.g. exploratory, pre-clinical and clinical stages.
1. Exploratory stage – It is the basic research in the laboratory of the conceptual idea and development of an antigen against the disease against which a vaccine needs to be produced which usually takes 2–4 years’ timeframe.
2. Pre-clinical stage of development – It uses a platform of tissue-culture and animal testing to assess the safety of the vaccine. They may also suggest the safest starting dose for the next phase of research as well as the safest method of administering the covid vaccine. This stage usually takes 1–2 years and out of 100 potential candidates, 6 usually pass through this stage.
3. Clinical stages of development – Consist of at least 3 stages and the 4th post-marketing safety assessment is also mandatory. These are performed on Human volunteers.
- In Phase I, the main aim is to assess the safety as well the type of immune response the candidate vaccine may produce. The data is analysed and if it shows promising results, the trial progresses to the next phase.
- Phase II vaccine trial is randomized and well-controlled and includes a placebo group. The goals of Phase II clinical trial are to review the candidate vaccine’s safety, immunogenicity, proposed doses, schedule of immunisation and route of administration.
- In Phase III of the trial, the immunogenicity of the trial vaccine is tested, e.g. production of critical levels of antibodies/ cell-mediated immunity and whether it prevents infection by protecting from the disease.
- Phase IV: Many manufacturing companies undertake a Phase IV trial for safety, efficacy and other potential uses which are optional studies after a vaccine is released.
List of all Covid Vaccines & their stages:
The efforts on coronavirus vaccine began initially in China as soon as the outbreak of coronavirus erupted and then world-over as the disease was declared a pandemic by WHO. Eventually, each country got into the race of developing the vaccine to be 1st in the world to safeguard its population & have an advantage over other countries.
Covid 19 pandemic is raging, even escalating. That puts pressure on all the countries to rush for a covid vaccine. Under such pressure, countries may authorize emergency use of a vaccine on specified groups without waiting for the completion of Phase III trials which could be harmful. We all have shown great patience till now, let’s continue the same by taking all the safety measures & following Government guidelines.
COVID-19 vaccine drive –
More than 80 million people in India have received at least one dose of a coronavirus vaccine and 11.1 million people have been fully vaccinated in what is the world’s biggest inoculation drive. Here’s how you can book a COVID-19 vaccine for your loved ones.
From March 1 onwards, all people above the age of 60 will be eligible to receive the COVID-19 vaccine. This is the second phase of India’s COVID vaccination programme and it will benefit 10 crore people across the whole nation.
|ChAdOx1-S||Oxford University and has been licensed to AstraZeneca||The United Kingdom and India||Phase 3||South Africa has halted use of the AstraZeneca-Oxford coronavirus vaccine after evidence emerged that the vaccine did not protect clinical-trial participants from mild or moderate illness caused by the more contagious virus variant that was first seen in the country.|
|BNT162b2 Vaccine||Pfizer in collaboration with BioNTech & Fosun Pharmaceuticals||USA, Germany & China||Concluded Phase 3
U.K regulator on Dec 2 declared the vaccine for use.
|FDA have described changes to the guidelines for the transportation and storage of the Pfizer-BioNTech vaccine. They explain that it can now be transported and stored at conventional temperatures commonly found in pharmaceutical freezers for a period of up to 2 weeks.|
If the FDA grants Pfizer’s request, the change could significantly speed up the vaccine rollout in the United States.
|EpiVacCorona||Vektor Centre, Novosibirsk||Russia||Given regulatory approval||A clinical trial with 40,000 volunteers to begin soon|
|mRNA-1273 Vaccine||Moderna along with NIH||United States||Phase 3||vaccine shows ‘no specific safety concerns. Results of the first analysis to be published by end of November. Early data shows 95% efficacy.|
|Sputnik V Vaccine||Gamaleya National Research Centre of Epidemiology and Microbiology||Russia||Developed.
Inadequate reports to prove the Vaccine’s efficacy and safety.
|Phase 3 results analysis shows 92% efficacy. Phase 2 & 3 Trials in India to begin soon. Approved in Russia.|
|Covaxin||Bharat Biotech||India||Rollout begun||The most reliable longer-term protection against coronavirus is provided through vaccination, experts said noting that the immunity afforded by the presence of antibodies might be expected to last only several months.|
|ZyCoV-D||Zydus Cadila||India||Phase 1 & 2||Has also begun working on a COVID drug to treat patients|
|CoronaVac Vaccine||Sinovac Life Sciences Co. Ltd. (China) in collaboration with Institution Butantan||China & Brazil||Phase 3||Trials halted in Brazil. Turkey and Indonesia begin late-phase human trials|
|CanSino Biologics company in collaboration with Beijing Institute of Biotechnology||China||Phase 3||Russia & Pakistan to begin Phase 3 trials|
|NVX-CoV2373||Novavax||US||Phase 3||Signed an agreement with SII to provide vaccine to low and middle-income countries post-approval|
|Janssen COVID-19 vaccine||Johnson & Johnson||US||Phase 3||Preparations underway to roll out 1 billion doses in 2021|
|Sanofi COVID-19 vaccine||Sanofi Pasteur in partnership with Translate Bio & GlaxoSmithKline||US & UK||Phases 1 & 2||Phase 3 trials to commence by end of December|