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 vaccine for the disease.
What are the Stages of development for a Vaccine?
The development of 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 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 analyzed 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 immunization 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 COVID-19 vaccines 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.
|ChAdOx1-S||Oxford University and has been licensed to AstraZeneca||The United Kingdom and
|Phase 3||Strong immune response observed among the elderly. Late-stage clinical trial results being analyzed, SII has produced 40 million doses ready to roll out.|
|BNT162b2 Vaccine||Pfizer in collaboration with BioNTech & Fosun Pharmaceuticals||USA, Germany & China||Phase 3||Final analysis shows 95% efficacy. Preliminary data shows 90% efficacy|
|EpiVacCorona||Vektor Centre, Novosibirsk||Russia||Given regulatory approval||Clinical trial with 40,000 volunteers to begin soon|
|mRNA-1273 Vaccine||Moderna along with NIH||United States||Phase 3||Results of 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.|
|Covaxin||Bharat Biotech||India||Entered Phase 3||26,000 people across 25 cities enlisted for 3rd phase trial|
|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|
Covid 19 pandemic is raging, even escalating. That puts pressure on all the countries to rush for a 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.