05 January,2021 08:57 AM IST | Mumbai | Vinod Kumar Menon
A health worker conducts the COVID-19 vaccination mock drill in the dry run at Duttabad primary health center in Kolkata on Jan 2. Pic/PTI
AS India is all set to begin vaccinations against COVID-19, health experts have raised concerns about allergic reactions as a side effect. Allergic reactions to the vaccines were reported in the UK and USA, and authorities advised people with allergies to refrain from taking the vaccines.
Allergy experts in India, state that nearly 30 per cent of the Indian population (urban and rural) are allergic to something or the other. They say the vaccine drive should begin only after proper screening and in hospitals (Pvt /Govt) where lifesaving equipment and medical experts are available to tackle any serious spontaneous allergic reaction - anaphylaxis - or peripheral neuropathy (damage to nerves outside of the brain and spinal cord).
Health workers show the victory sign after the COVID-19 vaccination dry run at a government hospital in Ranchi on Jan 2. Pic/PTI
"Usually vaccines are safe, but in few cases, they do show some allergic reactions in adults / children, who may be sensitive to the content. Usually such reactions are seen after sometime of administering the vaccine and can be easily tackled by existing medical staff, who are trained to handle minor allergic reactions. But the area of concern is a spontaneous allergic reaction called anaphylaxis (severe, potentially life-threatening allergic reaction), which occurs within minutes of administering the vaccine. Hence, it is important that all vaccination is be done under institutional care (government or private), where lifesaving equipment and experts are available at both rural and urban areas," said Dr Jacob John, renowned virologist, who has developed numerous vaccines.
Dr Wiqar Shaikh, senior allergy and asthma specialist and professor of medicine at Grant Medical College and Sir JJ Group of Hospitals said that the SARS-CoV2 vaccine has been approved in different countries across North America, Europe and Asia. There are several reports of allergic reactions to these vaccines particularly from the UK and USA.
According to Dr Shaikh, "The UK reported cases of anaphylaxis in two women, who had known food and drug allergies. A female health care worker in the USA who had no known allergies had an anaphylactic reaction within 10 minutes of receiving the first dose of the vaccine. Since then, several more cases of anaphylaxis associated with one of the vaccines have been reported in the USA. The incidence of anaphylaxis associated with this vaccine appears to be approximately ten times higher than incidences reported with all previous vaccines." Anaphylaxis is a serious multisystem reaction with rapid onset and can lead to death by asphyxiation, cardiovascular collapse, and other complications. It requires prompt recognition and treatment to halt the rapid progression of life-threatening symptoms.
Dr Shaikh added that a Boston doctor also developed a severe allergic reaction after receiving a vaccine. He said that in response to the two cases of anaphylaxis in the United Kingdom, the the Medicines and Health care products Regulatory Agency (MHRA), UK issued a warning on the vaccines, to exclude any person with a history of allergy/anaphylactic reaction to a food, drug, or vaccine. This has now been widely circulated by the British Society for Allergy and Clinical Immunology. The Centre for Disease Control and Prevention (CDC) in the USA has advised that patients with a history of allergy/anaphylaxis to vaccines, drugs or food should not receive the COVID-19 vaccination.
Dr Shaikh emphasized that with all the adverse effects to COVID-19 being highlighted across the world, the general public are getting worried and alarmed. As many as 42 per cent of Americans say they are unwilling to get a novel Coronavirus vaccine when one becomes available, for reasons varying from the unprecedented speed of the vaccines' development to a mistrust of vaccines and potential side effects, according to a recent Pew Research Center survey.
Dr Shaikh pointed out that opinion polls regarding COVID-19 vaccines have been conducted in India too. A Local Circles survey revealed that nearly 61 per cent of Indians said they are wary of a COVID-19 vaccine and will not take it even it is made available in 2021. A recent GOQii survey showed that 53 per cent of India's population is cautious about taking the vaccine. In a recent press briefing, the government of India admitted that there is always "the possibility of an adverse event" post-immunisation. Undoubtedly, India is not well prepared to tackle allergic reactions, particularly given the poor medical infrastructure in our rural and semi-rural areas. Dr. Shaikh also expressed concern that surveys in Europe have shown similar results. In Poland fewer than 40 per cent of people plan to get vaccinated. In Bulgaria, 45 per cent of the people have said they will not get vaccinated and 40 per cent plan to wait to see if any negative side effects appear. An Institut Francais D'Opinion Publique (IFOP) poll showed that only 41 per cent people in France would take the vaccine. Dr Shaikh concluded that opinion polls in India revealed that people are willing to wait for natural "herd immunity" to develop rather than risk taking COVID-19 vaccines.
"Since the start of the COVID-19 pandemic in November 2019 from Wuhan in China, the global focus has been on preparing effective vaccines for its control and elimination. The main focus during placebo-controlled Phase-III trials has been on the vaccine's efficacy in mounting an appropriate antibody response against the COVID-19 virus and the minimum adverse side effects. Fortunately, in the study samples varying between 20-40 thousand, a single digit number of volunteers developed allergic reactions such as anaphylaxis, skin rash, peripheral neuropathy (not of facial palsy type), and occasional malaise that is common with tissue culture-based vaccines," said Dr Subhash Hira, professor of Global Health at the University of Washington-Seattle, USA.
Said Dr Hira, "During the trials, a vaccine manufacturing pharma company said that there were no anaphylaxis cases. However, CDC, Atlanta recorded six severe anaphylaxis cases in the first million vaccines injected in the US and Europe. All volunteers recovered without any adverse outcomes with the use of epinephrine. However, similar allergic reactions might occur when India starts its massive exercise using the adenovirus conjugated tissue culture-based vaccines in February 2021, more so at district and rural setups."
"It is a good caution for vaccine implementers to plan for specific precautions to prevent allergic reactions (develop appropriate rapid patch tests) before the injection and thereafter, manage allergic reactions well. In case of any unforeseen severe disability or death caused by the vaccine, the national health insurance requires to design a plan to legalize payment of compensation to next of kin," he said.
Dr Hira concluded, "It's time for all world leaders of science and governments to reconnect and introspect as to why all the best science and medical institutions have failed to throw up viable solutions for COVID-19 and other impending pandemics."
mid-day reached out to Dr PC Kathuria, Senior Consultant, Department of Allergy & Asthma, BLK Super Specialty Hospital & National Allergy Centre, New Delhi, who conducts the training course in Allergy testing and Immunotherapy at National Allergy Center.
Both the UK and USA have stated that people with allergies should not be given COVID-19 vaccines. Do you think India should first screen people with allergies?
The risk of COVID-19 vaccines is very small except in individuals who have a history of anaphylaxis, grade IV (urticaria, shortness of breath and low BP) allergy to food, drugs, insect venom, sensitivity to PEG (Polyethylene glycol/ polysorbate). In such individuals COVID-19 vaccine should be given under observation of a physician. Even these individuals do not need to avoid the vaccine as no death has been reported so far. There are two components in the vaccine- 1) polyethylene glycol, which is a chemical found in many foods, cosmetics and medications and 2) lipid nano-particles, that encapsulate the messenger RNA (a genetic component in the vaccine), tiny spheres of fatty material. The PEG-YLATION of nano particles can have substantial disadvantages with reference to the efficacy and safety of COVID-19 vaccine.
Anaphylaxis is difficult to detect except in people having a history of recurrent severe allergic reaction to a food, drug or chemical or with high level of serum tryptase in blood.
But even these individuals should not cancel the beneficial effects of the vaccine. They only need monitoring for one hour after the COVID-19 vaccine is administered, for the occurrence of immediate adverse reaction.
What are the probable side effects, and do we have medical support facility in both Urban and Rural areas in case of any mass scale allergic reaction across the country?
In India, we have already pre-existing perfect immunization programmes. Under the same infrastructure we can cope with any adverse reaction due to COVID-19 vaccine. There are tolerable side-effects as fever, headache and pain at the site of reaction. If severe life-threatening reaction occurs, emergency kit containing injection adrenaline, anti-histamine, analgesic should be provided asa support to the vaccine provider.
What care or precaution needs to be taken before, after giving the vaccine?
The vaccination provider should have appropriate medication and equipment (epinephrine, stethoscope, anti-histamine, blood pressure cuff, timing devices to check pulse) at all COVID-19 vaccination centers. People who might be at high risk of anaphylaxis (life-threatening reaction) should stay at the vaccination center for minimum one hour (60 minutes) after their vaccine shot, so that they can be treated if necessar
Do you think, the number of COVID-19 cases in India have come down drastically? Is it due to herd immunity setting in?
Herd immunity is still questionable and needs surveillance setting. The number of the cases have decreased because of many compounding factors as new variant strain may be less virulent/lethal but may be more infectious; or weather changes; change in our social behaviour (social distancing, masks and regular hand-washing).
