A health worker displays empty vials of Covaxin in Guwahati. File
| Photo Credit: AP

The story so far: The Indian Council for Medical Research (ICMR) issued a letter to the researchers of Banaras Hindu University last week, countering their study on the side effects of India’s indigenous vaccine for COVID — Covaxin. In a rejoinder sent a couple of days after the publication of the research paper in a peer-reviewed journal, ICMR head Rajiv Bahl claimed that his institution had been incorrectly and misleadingly acknowledged in the paper. He pointed out what he called ‘critical flaws’ in the ‘poorly-designed study’. Notably, the ICMR was involved in developing Covaxin along with Bharat Biotech.

What did the BHU study conclude?

Adolescent girls and those with co-morbidities were at a higher risk of adverse events after receiving Bharat Biotech’s BBV152 (Covaxin) vaccine against COVID-19, BHU researchers said. Nearly a third of the participants reported adverse events of special interest (AESI). The one-year observational, follow-up study titled ‘Long-term safety analysis of the BBV152 coronavirus vaccine [Covaxin] in adolescents and adults: Findings from a one-year prospective study in North India’, also said that serious adverse events occurred in 1% of BBV152 recipients, and that extended surveillance is warranted following the vaccine administration.

Viral upper respiratory tract infections were reported in 47.9% adolescents and 42.6% adults, as per the study. New onset skin and subcutaneous disorders, general disorders, and nervous system disorders were the common AESIs in adolescents. General disorders, musculoskeletal disorders, and nervous system disorders were the common AESIs in adults. Menstrual abnormalities were noticed in 4.6% of female participants. Ocular abnormalities and hypothyroidism were observed in 2.7% and 0.6% of the participants, respectively. Among the serious AESIs (1%), stroke and Guillain-Barre syndrome were identified in 0.3% and 0.1% of the participants, respectively.

In response to this, Bharat Biotech, the vaccine manufacturer which worked with the ICMR’s own National Institute of Virology to develop the vaccine candidate, said for such a study in safety to be effective and informative, and for it to avoid investigator bias, some data points were also required. This included the AESI safety profile of the subjects prior to their participation in the study; a comparison of the safety profile of non-vaccinated subjects during the course of the study; a comparison of the safety profile of subjects who received other vaccines during the course of the study etc.

What did ICMR object to?

In his letter, Dr. Bahl said ICMR was not associated with the study and had not provided any financial or technical support. He alleged that the authors had acknowledged ICMR for research support without prior approval or intimation to the institution, calling this “inappropriate and unacceptable.”

With reference to the study itself, he claimed there were critical flaws: the study had no control arm of unvaccinated individuals for comparison with the vaccinated group, and therefore, the reported events in the study cannot be linked or attributed to COVID-19 vaccination; it did not provide background rates of patterns observed in the general population, and thereby made it impossible to study the observed events in the post vaccination period. Further, Dr. Bahl claimed there was no baseline information of study participants; the study tool was inconsistent with the AESI as defined in the reference paper, and the method of data collection (participants were contacted over the telephone, and their responses recorded without any clinical confirmation).

He further asked the researchers to remove the acknowledgement to ICMR and publish an erratum. His letter also called to retract the paper, with a remark: “This paper implicitly makes conclusions about vaccine safety that are not supported by evidence.” The BHU recorded that it had received the communique addressed to its researchers. The researchers have communicated their responses to the ICMR.

What was the fallout?

Most researchers were shocked by the response of the ICMR, terming it as “academic censorship.” Multiple accounts of doctors and researchers on social media also pointed out that the ICMR developed the vaccine along with the company, and not declaring its vested interest was also a serious lapse in research terms. Among those who formulated an official response, foremost was the Universal Health Organisation (UHO), a group of researchers, doctors, and public health experts, who echoed the research ecosystem’s shock at the belated denial. The UHO wrote an open letter to the ICMR stating the study filled a key gap in terms of field data, analysing the safety of Covaxin.

“While we were hoping and expecting that the ICMR would build upon this study, address its shortcomings, and elevate the standards of vaccine safety, we are aghast to come across letters sent by ICMR asking for the retraction of the paper, and threatening the authors of the study,” it said. On the point of not having a control group, the letter said, it was indeed a shortcoming but had been admitted in the study itself. Besides, this actually points to the fact that it was the ICMR that has access to the data with the control group — the original phase 3 trials of Covaxin. Neither the ICMR nor the company had published the long-term safety trials, it charged. While using telephonic interviews was not ideal, it has been used by ICMR in the past, even in papers on COVID vaccines. To call for the retraction of the BHU paper on these lines was unbecoming of a scientific institution of ICMR’s stature, the letter added.

New Delhi:

In the wake of pharmaceutical giant AstraZeneca admitting in a UK court that its Covid vaccine can cause blood clots in rare cases, a group of doctors on Thursday expressed deep concern over the safety of the Covishield vaccine manufactured by the Serum Institute of India.

At a press conference, the doctors, under the banner of the Awaken India Movement (AIM), urged the government to review the science behind all Covid vaccines and audit their commercialisation as well as implementation of active surveillance and monitoring mechanism to ensure vaccine adverse events are identified as early as possible.

“The government has wholly ignored the rising number of cases of tragic deaths post-Covid vaccination all the while and continues to promote Covid vaccines as ‘safe and effective’, without scientific investigation and invoking epidemiology,” Dr Tarun Kothari, a radiologist and an activist, said at the press conference.

The world is learning about a side effect of the Covid vaccine called Thrombosis with Thrombocytopenia Syndrome (TTS), he said.

When the COVID-19 vaccines were being administered, not many people were aware that it was being done without the completion of phase-3 trials. Administration of COVID-19 vaccines was started without the manufacturers having complete information and data on the possible short-term or long-term side effects, or fatalities, said Dr Sujata Mittal, a gynaecologist and oncologist.

There is an already low awareness around vaccine injuries, especially in India, she said.

Thousands of women reported abnormalities in their menstrual cycles, which was confirmed much later as a side effect of the vaccine in a study published in September 2022, she added.

“The Awaken India Movement (AIM) has been collecting details of Covid Vaccine deaths covered by media/social media in India and sharing them with various high authorities of the country since 2021, when the vaccination began. The government has failed to respond to our repeated requests to investigate deaths and debilitation from adverse effects of vaccination,” Dr Kothari said.

The AIM urged the government of India to compensate all the victims of Covid vaccines, including their family members, through a mechanism that involves vaccine manufacturers as well.

“We also demand establishing fast track courts and vaccine courts to provide swift justice to the vaccine injured and their families,” Dr Mittal said.

Besides, active surveillance and monitoring mechanisms should be implemented to ensure vaccine adverse events are identified as early as possible and early treatment protocols must be created and widely publicised so that lives can be saved, she stated.

“Review science behind all Covid vaccines and audit their commercialisation,” Dr Kothari said.

The United Kingdom-based AstraZeneca has started global withdrawal of its COVID-19 vaccine, which was provided in India as ‘Covishield’ in partnership with the Serum Institute of India, days after it admitted to rare side effects of blood clotting and lowering of platelet counts.

The withdrawal has been initiated due to a surplus of available updated vaccines since the pandemic, the company said in a statement.

In India, the company’s partner Serum Institute of India said it has stopped the manufacturing and supply of additional doses of Covishield since December 2021 while reiterating that it had disclosed all rare to very rare side effects, including TTS, in the packaging insert in 2021.

AstraZeneca had partnered with Oxford University to develop the COVID-19 vaccine, which was sold as Vaxzevria in Europe. 

(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)

File picture of a nurse holding vials of AstraZeneca vaccine against COVID-19
| Photo Credit: AP

AstraZeneca said on Tuesday it had initiated the worldwide withdrawal of its COVID-19 vaccine due to a “surplus of available updated vaccines” since the pandemic.

The company also said it would proceed to withdraw the vaccine Vaxzevria’s marketing authorisations within Europe.

ALSO READ | AstraZeneca’s submission in U.K. court nothing new, say doctors over Covishield’s potential to cause blood clots

“As multiple, variant COVID-19 vaccines have since been developed there is a surplus of available updated vaccines,” the company said, adding that this had led to a decline in demand for Vaxzevria, which is no longer being manufactured or supplied.

According to media reports, the Anglo-Swedish drugmaker has previously admitted in court documents that the vaccine causes side-effects such as blood clots and low blood platelet counts.

The firm’s application to withdraw the vaccine was made on March 5 and came into effect on May 7, according to the Telegraph, which first reported the development.

London-listed AstraZeneca began moving into respiratory syncytial virus vaccines and obesity drugs through several deals last year after a slowdown in growth as COVID-19 medicine sales declined.

Image used for representative purpose only.
| Photo Credit: Reuters

The U.S. approved updated COVID-19 vaccines Monday, hoping to rev up protection against the latest coronavirus strains and blunt any surge this fall and winter.

The Food and Drug Administration decision opens the newest shots from Moderna and Pfizer and its partner BioNTech to most Americans even if they’ve never had a coronavirus vaccination. It’s part of a shift to treat fall updates of the COVID-19 vaccine much like getting a yearly flu shot.

There’s still another step: The Centers for Disease Control and Prevention must sign off. A CDC advisory panel is set to issue recommendations Tuesday on who most needs the updated shots. Vaccinations could begin later this week, and both the COVID-19 and flu shot can be given at the same visit.

A third vaccine maker, Novavax, said its updated shot is still being reviewed by the FDA.

COVID-19 hospitalizations have been rising since late summer although –- thanks to lasting immunity from prior vaccinations and infections –- not nearly as much as this time last year.

But protection wanes over time and the coronavirus continually churns out new variants that can dodge prior immunity. It’s been a year since the last time the vaccines were tweaked, and only about 20% of adults ever received that earlier update.

“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” FDA vaccine chief Dr. Peter Marks said in a statement. “We very much encourage those who are eligible to consider getting vaccinated.”

Just like earlier vaccinations, the fall round is cleared for adults and children as young as age 6 months. FDA said starting at age 5, most people can get a single dose even if they’ve never had a prior COVID-19 shot. Younger children might need additional doses depending on their history of COVID-19 infections and vaccinations.

The FDA pointedly isn’t calling this latest round a “booster” but instead a vaccine updated to better match the currently circulating virus. The new recipe targets an omicron variant named XBB.1.5 — replacing outdated combination vaccines that mixed protection against the original coronavirus strain and an older version of omicron.

And while even the XBB.1.5 variant is no longer dominant, FDA determined that it’s close enough to coronavirus strains causing most COVID-19 illnesses today to offer good cross-protection. Like earlier versions, they’re expected to be most protective against COVID-19’s worst consequences rather than mild infection.

But while the FDA’s decision allows for wide use of the updated shots, the CDC will decide how strongly different groups are urged to get them.

Federal officials have said the shots still will be free to most Americans through private insurance or Medicare. But for the uninsured or underinsured, the CDC is working with health departments, clinics and certain pharmacies to temporarily provide free shots.

Geneva:

A UN anti-racism committee on Thursday urged rich countries — particularly Britain, Germany, Switzerland and the United States — to waive coronavirus vaccine patents and said they violated a guarantee against racial discrimination.

In June 2022, World Trade Organization member countries reached an agreement authorising developing nations to lift Covid-19 vaccine patents for five years, but further talks on the issue have stalled.

The UN Committee on the Elimination of Racial Discrimination, a group of 18 independent human rights experts whose views are not binding, said the deal has not done enough to reduce disparities.

According to the latest WHO data, 32 percent of the world’s population has received at least one booster or additional vaccine dose, but in some developing nations the figure is less than one percent, it said.

Rich countries’ “persistent refusal” to waive intellectual property rights “raises concerns” about their obligations under the International Convention on the Elimination of All Forms of Racial Discrimination, the committee added.

It said Covid-19 remained a serious public health issue with “devastating” impacts falling disproportionately on people of African or Asian descent, ethnic minorities, Roma communities and Indigenous peoples.

The inequality could be “significantly mitigated” by sharing access to intellectual property rights to life-serving vaccines, treatments and technologies “currently reserved by a few countries in the global North”, it said.

(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)