Two vaccines that have been granted emergency use authorization by the Central Drugs Standard Control Organization (CDSCO) in India are Covishield® (AstraZeneca’s vaccine manufactured by Serum Institute of India) and Covaxin® (manufactured by Bharat Biotech Limited in collaboration with the Indian Council of Medical Research (ICMR)-National Institute of Virology (NIV). Recently, Russia’s Sputnik V Covid-19 vaccine has also been launched in India. The first consignment of imported doses of the Sputnik V vaccine landed in India on 1 May.
The safety and efficacy data from clinical trials of vaccine candidates are examined by the Drug Regulator of our country before granting the license for the same. Hence, all the COVID-19 vaccines that receive license will have comparable safety and efficacy.
Covishield® has also been approved for use in 40 other countries while Covaxin® has been approved in 9.
Vaccines help people develop immunity to a virus or other germ. A vaccine introduces a less harmful part of that germ — or something created to look or behave like it — into a person’s body. The body’s immune system develops antibodies that fight that particular germ and keep the person from getting sick from it. Later, if the person encounters that germ again, their immune system can “recognize” it and “remember” how to fight it off.
The coronavirus that causes COVID-19 has spikes of protein on each viral particle. These spikes help the viruses attach to cells and cause disease. Some of the coronavirus vaccines in development are designed to help the body “recognize” these spike proteins and fight the coronavirus that has them.
An effective vaccine will protect someone who receives it by lowering the chance of getting COVID-19 if the person encounters the coronavirus. More important is whether the vaccine prevents serious illness, hospitalization and death. At this time, both the available vaccines are effective at preventing serious illness, hospitalization and death from COVID-19. Widespread vaccination means the coronavirus will not infect as many people. This will limit spread through communities and will restrict the virus’s opportunity to continue to mutate into new variants.
Source: Johns Hopkins Medicine
The efficacy of the Covishield® vaccine is around 70% as per the global reports. Covaxin® has demonstrated an interim efficacy of around 78% in preventing COVID-19 in those without prior infection after the second dose. The newly introduced Sputnik V® vaccine has demonstrated an efficacy of 91.6%.
Vaccines do not always need to have an exceptionally high effectiveness to be useful, for example the influenza vaccine is 40-60% effective yet saves thousands of lives every year. Vaccines with an efficacy of over 50% are considered effective in curbing this pandemic.
Getting infection after vaccination is known as breakthrough infection.The chances of infection after full vaccination are relatively less. In India, just 0.04% of such re-infection cases have been reported so far. As per ICMR, among 10.03 crore people who had taken only the first dose of Covishield®, 17,145 had got infected. That translates into a 0.02% prevalence. Among the 1.57 crore people who received the second dose as well, 5,014, or about 0.03%, had got infected later.
Again, about 1.1 crore doses of Covaxin® have been administered until now. Of the 93.56 lakh who took only the first dose, so far 4,208 have got the infection. That is about 0.04% of the total. Among the 17.37 lakh who have taken the second shot, only 695 had been infected, again 0.04%. Further, most of those who tested positive are frontline workers and healthcare workers. They are prone to more occupational exposure.
The Union Ministry of Health and Family Welfare accepted the recommendations by the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) on 19/05/2021. It states that in all individuals having lab test proven SARS-2 COVID-19 illness, the COVID-19 vaccination should be deferred by 3 months after recovery.
The COVID-19 vaccine was launched on 16th January, 2021. The first group includes healthcare and frontline workers. The second group to receive COVID-19 vaccine are persons over 60 years of age as of March 1st, 2021 and persons between 45 and 59 years with comorbid conditions. This group started receiving vaccinations from March 1st, 2021. Those who are above 45 years of age will be able to take the vaccination from April 1st, 2021. The government is rolling out a nationwide immunisation program to vaccinate all adults above the age of 18 years from May 1st, 2021. However, the roll out plan is different in different states.
Vaccination for COVID-19 is voluntary. However, it is advisable to receive the complete schedule of COVID-19 vaccine for protecting oneself against this disease and also to limit the spread of this disease to close contacts including family members, friends, relatives and co-workers.
Yes, the COVID-19 vaccines being given in India are as effective as any vaccine being given in other countries. Various phases of vaccine trials have been undertaken to ensure its safety and efficacy.
Covishield® has also been approved for use in 40 other countries while Covaxin® has been approved in 9.
Source: Covid-19 Vaccine Tracker
The vaccine cannot give you COVID-19 infection, and 2 doses will reduce your chance of becoming seriously ill. We do not yet know how much it will reduce the chance of you catching and passing on the virus. So, it is important to continue to protect those around you.
Remember to protect yourself and your family, friends and colleagues you MUST still follow any national or local restrictions and:
- practise social distancing
- wear a face mask
- wash your hands regularly
- open windows to let fresh air in
Yes. Vaccination protects you from getting seriously ill and dying from COVID-19. For the first 14 days after getting a vaccination, you do not have significant levels of protection, then it increases gradually. For a single dose vaccine, immunity will generally occur two weeks after vaccination. For two-dose vaccines, both doses are needed to achieve the highest level of immunity possible.
While a COVID-19 vaccine will protect you from serious illness and death, we still don’t know the extent to which it keeps you from being infected and passing the virus on to others.
So, it is absolutely necessary that everyone who has received the COVID-19 vaccine should continue to follow the COVID-19 appropriate behaviour i.e., mask, do gaj ki doori and hand sanitization to protect themselves and those around from spreading the infection.
Because COVID vaccines have only been developed in the past months, it’s too early to know the duration of protection of COVID-19 vaccines. Research is ongoing to answer this question. However, it’s encouraging that available data suggest that most people who recover from COVID-19 develop an immune response that provides at least some period of protection against reinfection – although we’re still learning how strong this protection is, and how long it lasts. Hence, continuing the use of masks, handwashing, physical distancing and other COVID-19 appropriate behaviours is strongly recommended.
The COVID-19 vaccines are expected to provide at least some protection against new virus variants and are effective at preventing serious illness and death. That’s because these vaccines create a broad immune response, and any virus changes or mutations should not make vaccines completely ineffective. Therefore, all vaccines are expected to provide reasonable amount of protection against the mutated virus also. Based on the available data the mutations as reported are unlikely to make the vaccine ineffective.
If any of these vaccines become less effective against one or more variants, it will be possible to change the composition of the vaccines to protect against these variants. Data continues to be collected and analysed on new variants of the COVID-19 virus.
As per experts, there is no evidence of alcohol impairing the effectiveness of the vaccine.
Both the vaccines are safe but in case of any discomfort or complaint, ask the beneficiary to visit the nearest health facility and/or call the health worker whose phone number is given in the Co-WIN SMS received after vaccination.
When someone is vaccinated, they are very likely to be protected against the disease. But not everyone can be vaccinated at the same time. These unvaccinated people can still be protected if they live in and amongst others who are vaccinated. When a lot of people in a community are vaccinated the virus has a hard time circulating because most of the people it encounters are immune. So the more that others are vaccinated, the less likely people who are unable to be protected by vaccines are at risk of even being exposed to the harmful pathogens. This is called herd immunity.The percentage of people who need to be immune in order to achieve herd immunity varies with each disease. For example, it’s 95% for measles, however the proportion of the population that must be vaccinated against COVID-19 to begin inducing herd immunity is not known.
Vaccinating not only protects yourself, but also protects those in the community who are unable to be vaccinated.
Covishield® vaccine, manufactured by the Serum Institute of India, is a Viral Vector-based Technology which is also used to manufacture Ebola vaccine.
Covaxin® vaccine, manufactured by Bharat Biotech, is a Whole-Virion Inactivated Coronavirus Vaccine which is also used to manufacture vaccines like Influenza, Rabies and Hepatitis- A.
Emergency Use Authorization (EUA) is a regulatory mechanism to allow the use of vaccines and medicines to prevent and/or reduce the impact of life-threatening diseases or conditions as caused by COVID-19. However, before grant of the EUA, rigorous assessments of laboratory and clinical trial data, including data on quality, safety, production of protective antibodies and efficacy is conducted. Safety is a particularly critical aspect of this scrutiny and a risk-versus-benefit evaluation is done in the context of a public health emergency. Full licensure is obtained when the manufacturer submits the complete data. EUA by Indian regulators is aligned with global guidelines.
Concept of EUA always existed to save the lives of people all over the world with vaccines and medicines for life threatening diseases while companies continue to obtain additional safety and effectiveness information to enable full licensure. Previously, EUAs have been granted to vaccines for outbreaks due to Anthrax, Ebola, Enterovirus, H7N9 Influenza, and Middle East Respiratory Syndrome. As of January 2021, nine COVID-19 vaccines were in emergency use in numerous countries around the globe.
With the goal of vaccinating 300 million people every quarter, costs are mounting. Doctors say it may take two years to vaccinate the entire population. The first round of immunisations has been subsidised by the government and is free for India’s 30 million health workers, older people, and frontline workers. Each dose of Covaxin® costs 295 rupees (£2.93 versus £19-£28 for the Moderna® vaccine and £26.70 for the Pfizer/BioNTech® ). Moreover, Bharat Biotech is providing the first 1.65 million doses at no cost to the government. This makes the Indian vaccine the cheapest purchased by any country in the world at 206 rupees per shot for the 5.5 million doses the government currently has on order. The government has capped the price of the vaccine sold in the private market, with private hospitals able to charge up to 250 rupees.
Covaxin® does not require storage at sub-zero temperatures, which would be hard to maintain in India’s climate and with the frequent power cuts in rural areas. It is available in multi-dose vials and is stable at the 2-8°C that ordinary refrigeration can achieve.
Bharat Biotech says it has a stockpile of 20 million doses of Covaxin® for India and is in the process of manufacturing 700 million doses at its four facilities in two cities by the end of the year. It says it can provide 300 million shots annually.
Covaxin®’s phase I trial to assess safety and immunogenicity is published. All 375 subjects who received the vaccine had notably elevated antibody response.
The phase II trial result has not yet been published in a peer reviewed journal, but a preprint has been posted on MedRxiv. The provisional data indicate enhanced immune response and tolerable safety outcomes.
Since November, 25 800 participants have been enrolled in ongoing phase III trials. Bharat Biotech released interim efficacy data on 3 March 2021, which showed a clinical efficacy of 81%.
Source: Bharat Biotech