Data Deficit Around Deaths Post COVID-19 Vaccine Creates Hesitancy
It is crucial to report on the adverse events after vaccination to reduce errors and build trust in the system.
On 16 March, a group of doctors, lawyers and journalists wrote to the central government asking for an “urgent investigation of deaths and serious adverse events following administration of COVID-19 vaccine.”
The reason behind the hesitancy towards a COVID-19 vaccine is not just online misinformation but also genuine queries that people have and a lack of transparency on the part of the vaccine manufacturers and the government.
Despite having thousands of data points proving the vaccine’s safety, a few unanswered questions are creating a data deficit that the purveyors of misinformation are using to their advantage.
The government has formed a National Adverse Events Following Immunisation (AEFI) Committee to study all the adverse events following vaccinations. According to Dr NK Arora, a member of the national COVID-19 task force, 79 deaths have been reported to have occurred after COVID-19 vaccination as of 26 March, but none of them has been directly linked to the vaccine by the committee. Moreover, the findings of only two of these deaths have been made public so far, a point that was raised in the letter. Arora did mention that data on the deaths will soon be shared on a public portal.
Lack of Clarity on AEFI
A survey conducted in January 2021 by Local Circles, of 17000 people, found that vaccine hesitancy was still at 62 percent. Of the hesitant lot, 59 percent were worried about the side-effects of the vaccine.
The lack of data on deaths following the COVID-19 vaccine is giving rise to social media posts that raise more questions.
For example, a 26-year-old doctor, Dr Hariharini died in Meenakshi Mission Hospital on 11 March, after spending almost a week on the ventilator. Viral messages on Facebook, Instagram and WhatsApp said that “she died after taking the vaccine”.
Although it is true that she received the first dose of the vaccine, she got it on 5 February, nearly a month before she fell ill, and doctors, in their initial investigation, have ruled out the COVID-19 vaccine as the reason behind the death.
Her story along with a photo of her and her husband was shared on Facebook, Twitter and WhatsApp. An Instagram handle called “covidvaccinevictims”, which regularly shared photos of people who died after getting the COVID-19 vaccine, also shared the story with a misleading caption.
“...26 years old from India died suddenly after getting the COVID-19 injection,” the post said, omitting the fact that the time difference between the vaccination and her death was over a month.
"We are not blaming the vaccine for the deaths. We are not an anti-vaccine lobby. But the cause of deaths should be investigated. Once done, this can help gain trust in the vaccine and avoid hesitancy,” Dr SP Kalantri, a physician from Sevagram, Maharashtra told The Hindu.
In the same report, virologist Dr Jacob T John also agreed upon the importance of establishing the cause of deaths. Both experts had, in January 2021, written to Health Minister Dr Harsh Vardhan and Drugs Controller General of India (DCGI) VG Somani, asking them to investigate the cause of the deaths and make the information public.
“Covid vaccine victims” also has a Telegram channel that has over 51,000 subscribers, proving that the story of Dr Hariharini is not an isolated one. The group posts news reports from all over the globe about deaths after vaccination.
It is important to note that most of these posts do not strictly classify as misinformation and therefore clear the strict policies set up by social media companies. They do, however, help in increasing vaccine hesitancy.
Gaps in Knowledge About COVID-19 Vaccine
Another place where there is a lack of clear communication is in the development process of vaccines, the scientific norms associated and the understanding of what makes the vaccine “safe” and “efficacious”.
Morality and ethics have often been issues that scientists and vaccine manufacturers have had to deal with for ages. Religion too plays an important role in deciding whether or not a vaccine gets accepted. Keeping that in mind, it is important to have clear communication from vaccine manufacturers about the ingredients used in the vaccine and the testing process.
The Indian-made Covaxin coronavirus vaccine does not use Foetal Bovine Serum (FBS) in its manufacturing process. However, one of the research papers published by Bharat Biotech mentioned the use of FBS while testing the efficacy of the vaccine in a ‘Syrian Hamster model’. Anti-vaccination groups used that information to reject the vaccine on ethical and religious grounds.
Although the information is available on Bharat Biotech’s website, it is not easy to access the information and even if one found it, they might find it difficult to skim through the scientific jargon to get their answers. Anti-vaxxers, on the other hand, provide people with the exact sheet of paper that helps prove their point.
Globally, the use of mRNA technology in the making of Pfizer and Moderna COVID-19 vaccines have also raised concerns and created a space for misinformation and conspiracy theories.
Many anti-vaxxers believe that the mRNA vaccines will alter people’s DNA and are made to depopulate the earth. Scientists, who have studied the technology, have maintained that the COVID-19 vaccine can’t alter human DNA.
Therefore, there is a need for clear communication and transparency from vaccine manufacturers, which will help in quashing misinformation at the source.
Who Takes the Blame - Pharma Companies or the Government?
Conspiracy theorists and misinformation peddlers propagate a narrative that the government is hand-in-glove with pharmaceutical companies. Both vaccine manufacturers and the government have to be transparent about the process of procurement, distribution and costs and legalities involved.
The Vaccine Manufacturers Association of India wrote to the Indian government seeking indemnity from lawsuits during the pandemic period.
They cited the USA’s Public Readiness and Emergency Preparedness Act 2005 (PREP Act), under which companies like Pfizer and Moderna get immunity from liability if something unintentionally goes wrong with their vaccines. However, the law does not protect the pharma companies in case of negligence, malpractice and lack of care.
The United Kingdom government also amended its laws to provide immunity from civil liability to vaccine manufacturers and health care workers. Pharma company AstraZeneca applied for a similar agreement with the European Union (EU) to protect themselves claims related to its COVID-19 vaccine. However, the EU didn’t disclose the details of the immunity or liability.
The Indian government said that it was yet to decide on providing indemnity to the Indian vaccine manufacturers. But the very conversation about providing legal immunity to vaccine manufacturers has led to posts like these.
The government, too, has not been transparent in the approval process. The Subject Expert Committee of Central Drugs Standard Control Organisation (CDSCO) approved the vaccines in India after sitting in long closed-door meetings. Their American and British counterparts provided detailed presentations and documentation of the approval process and described the vaccine at length.
The approval of the vaccines in India was announced in a press conference where the Director of Drugs Controller General of India read out a press release issued by the Ministry of Health and Family Welfare and didn’t take any questions. The press conference left several unanswered questions, especially about Covaxin, which resulted in several healthcare professionals refusing to take the vaccine.
The World Health Organisation (WHO) has, in 2019, said that “Vaccine Hesitancy” is one of the top 10 threats to global health. “Vaccine hesitancy – the reluctance or refusal to vaccinate despite the availability of vaccines – threatens to reverse progress made in tackling vaccine-preventable diseases,” the WHO report states.
In the UK, reports of all adverse events after vaccinations are available in the public domain for both AstraZeneca and Pfizer vaccines. In India, the daily updates on vaccination do not provide the details of adverse events. The authorities need to realise that by not putting out the data in the public domain, the trust in the system breaks, leading to vaccine hesitancy.
It is understood that the vaccine, like all other drugs, might have some side-effects. During an unprecedented time like the COVID-19 pandemic, it is important for the government to report on the side-effects accurately and follow up on them so that it reduces any errors in the system and helps build trust in the vaccine.
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