covaxin – Artifex.News https://artifexnews.net Stay Connected. Stay Informed. Sat, 29 Jun 2024 20:17:00 +0000 en-US hourly 1 https://wordpress.org/?v=6.6.1 https://artifexnews.net/wp-content/uploads/2023/08/cropped-Artifex-Round-32x32.png covaxin – Artifex.News https://artifexnews.net 32 32 What was the tussle over Covaxin IPR? | Explained https://artifexnews.net/article68349420-ece/ Sat, 29 Jun 2024 20:17:00 +0000 https://artifexnews.net/article68349420-ece/ Read More “What was the tussle over Covaxin IPR? | Explained” »

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Image for representation.
| Photo Credit: The Hindu

The story so far: The maker of the indigenous coronavirus vaccine, Covaxin, Bharat Biotech International Limited (BBIL), has admitted to an “inadvertent error” in patent filings to protect the vaccine’s Intellectual Property Rights (IPR). One of India’s leading biotechnology companies, it had failed to include scientists from the Indian Council of Medical Research (ICMR) as co-inventors in the Covaxin patent filings.

What kind of rights govern vaccine patents?

India’s patent laws govern both product and process patents. Product patents grant an inventor a monopoly over, say, a drug. Process patents bar competitors from making a similar drug using the same sequence of steps. In response to queries from The Hindu, Bharat Biotech said it had patented the process, namely of making a batch of vaccines from the virus strains that were provided by the ICMR-NIV (National Institute of Virology). This is the lab that has expertise in extracting viruses from blood samples, identifying its characteristics, conducting various tests to gauge its infectiousness and qualify it in comparison to related strains. However, preparing a vaccine out of this at an industrial scale is beyond the capabilities of a lab and requires a different order of facilities that only established vaccine manufacturers have. Covaxin is an inactivated version of COVID-causing coronavirus; once injected into the body it coaxes it into producing antibodies that can potentially protect against severe disease from a coronavirus infection. To do this effectively, an ‘adjuvant’ is added which increases the vaccine’s potency. Vaccine makers may have their own ways of bringing all of these steps together and, given the competitive nature of the field, strive to ward off competitors from imitating these processes to gain a temporary monopoly in the market and rake profits.

To be sure, while companies are free to file for a product or process patent in as many countries as they can afford, a patent is only granted after regulatory authorities grant them one or are convinced that this process is indeed novel or inventive. BBIL, as far is publicly known, hasn’t yet been granted these patents.

What were the roles of BBIL and ICMR?

BBIL had collaborated with the ICMR-NIV for all the steps in developing a vaccine. The two organisations had signed an agreement that spelt out each entity’s responsibilities. As ICMR is a public entity and because of the scale of the COVID crisis, there were Right To Information requests to make this agreement public. However, it was only in July 2021, that parts of the agreement were made public in Rajya Sabha.

Beyond transferring the strains and making vaccines, the agreement said, ICMR would also test these vaccines on animals — rodents to monkeys — and then on people to establish that the vaccine worked as intended. The ICMR also funded these clinical trials — ₹35 crore — and incurred costs in developing Covaxin. In return it was to get 5% of royalties that BBIL earned from the sale of Covaxin. Since the announcement of the BBIL and ICMR collaboration, it was generally accepted that both entities would contribute to the vaccine and would therefore hold “joint intellectual property rights,” as was stated in Parliament.

However, BBIL first told The Hindu that it made a distinction between the rights governing the making of the vaccine and the rights over the data generated from clinical trials. The ICMR hadn’t invested in the actual making of the vaccine and so wasn’t included in patent applications. However, a day after the matter became public, BBIL said it had made a mistake, and that it would be making amends by filing fresh applications that listed ICMR personnel as inventors. It is unclear what prompted this.

Why does being cited as an inventor matter?

IPR is a vast, complex domain and spans the minutest parts of the product invention process. As the development of pharmaceutical products involves a wide range of expertise, it is hard for single firms or entities to develop everything in-house. Just like the BBIL-ICMR collaboration, companies may enter into several licensing agreements — BBIL for instance had a technology licensing agreement with Virovax for the adjuvant — with other companies. If a single product thus involves multiple entities and collaborators, being listed as an inventor has a bearing on the sharing of intellectual property rights, royalties and even determining how a product can be used. There is no field of human activity that is untouched by disputes over IPR. In patent filings, not listing out all the inventors — in the U.S especially — could even lead to patent applications being rejected.



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The Hindu Morning Digest, June 23, 2024 https://artifexnews.net/article68322220-ece/ Sun, 23 Jun 2024 02:01:44 +0000 https://artifexnews.net/article68322220-ece/ Read More “The Hindu Morning Digest, June 23, 2024” »

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Students from various organisation protest over the NEET-UG and UGC-NET examinations issue outside Ministry of Education in New Delhi.
| Photo Credit: SHASHI SHEKHAR KASHYAP

NEET-PG postponed, CBI to probe NEET-UG allegations, NTA chief removed, as panel set up for agency overhaul

With questions being raised about the “integrity of certain competitive examinations”, the Health Ministry announced the postponement of the NEET-PG entrance examination “as a precautionary measure”, just hours before it was due to be held on June 23 morning. This followed on the heels of decision to remove Subodh Kumar Singh from his position as Director-General of the National Testing Agency, which has come under fire for an alleged paper leak and irregularities in the NEET-UG examination, and other examinations which it conducts.

1,563 candidates to retake NEET-UG on June 23

The retest is being conducted after the National Testing Agency (NTA) cancelled the scorecards of 1,563 students who were granted compensatory marks for loss of time due to a delay in six centres in Meghalaya, Haryana, Chhattisgarh, Gujarat and Chandigarh.

Six arrested in Jharkhand in NEET case; Sanjeev Mukhiya kingpin, says Economic Offences Unit

Investigation into the NEET paper leak case led the Bihar Police to neighbouring Jharkhand where police arrested six people from Deoghar on Friday night. A team led by officials of the Economic Offences Unit (EOU) brought the six to Patna for questioning. Deoghar Police said five Nalanda residents Paramjit Singh, Baldev Kumar, Prashant Kumar, Ajit Kumar, Rajiv Kumar, and one Panku Kumar, were arrested from a house near AIIMS-Deoghar.

Erred in not crediting ICMR as co-inventor of Covaxin, says Bharat Biotech

Hyderabad-based Bharat Biotech International Limited (BBIL) and manufacturer of Covaxin, India’s first indigenous Covid-19 vaccine, said it had made an “inadvertent mistake” in not including scientists from the Indian Council of Medical Research (ICMR) as ‘co-inventors’ in patent applications filed in India and abroad to protect the intellectual property rights around the vaccine. It would include their names in fresh filings for patent purposes, it said in a statement late on Saturday.

BSF to recalibrate deployment along Pakistan border in Jammu in the wake of terror strikes

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Hardik Pandya produced an all-round show while Kuldeep Yadav foxed Bangladesh batters with his guile as India all but assured themselves of a semifinals berth through a dominant 50-run victory in their second Super 8 game of the T20 World Cup here on Saturday.

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BHU’s Covaxin safety study riddled with major limitations https://artifexnews.net/article68211668-ece/ Sat, 25 May 2024 15:30:00 +0000 https://artifexnews.net/article68211668-ece/ Read More “BHU’s Covaxin safety study riddled with major limitations” »

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An observational study carried out by researchers from the Banaras Hindu University, Varanasi to assess the safety of Covaxin, particularly the long-term adverse events of special interest (AESIs) one year after vaccination, in adolescents and adults has been criticised by ICMR for the poor study design. However, till date, neither ICMR nor Bharat Biotech has published any Covaxin safety data after the drug regulator approved its roll-out in January 2021 in a “clinical trial mode” and wanted the vaccine recipients to be followed up for safety.

Though the researchers acknowledge all the limitations of the study, which is published in the journal Drug Safety, many of the limitations are so critical that they defeat the very purpose of the study. “Ideally, this paper should have been rejected at the peer-review stage. Simply mentioning the limitations, some of them critical to arrive at any useful conclusion, defeats the whole purpose of undertaking the study,” Dr. Vipin M. Vashishtha, director and pediatrician, Mangla Hospital and Research Center, Bijnor, says in an email to The Hindu. Dr. Gautam Menon, Dean (Research) &  Professor, Departments of Physics and Biology, Ashoka University shares the same view. Given the limitations of the study one can “certainly say that the study can’t be used to draw the conclusions it does,” Dr. Menon says in an email.

If the most glaring limitation of the study is the lack of a control group, the absence of data on background rates of adverse events of special interest (AESI) that have been assessed in the vaccinated participants makes it difficult to even find an association between the adverse events and the vaccine. However, Dr. Kishor Patwardhan from BHU and co-author of the paper in a tweet justifies the absence of a control group by saying that “in a longitudinal observational study, a traditional control group might not be feasible or necessary. Instead, researchers use the variability within the cohort over time to draw comparisons and identify associations”.

“The lack of a control arm is a serious limitation of the study and negates any useful inference and interpretation of the study’s findings. Further, they didn’t try to show a real upsurge in the rates of these common ailments in the vaccinated population as the background rates are not mentioned,” says Dr. Vashishtha. “Most of the symptoms the authors describe as adverse effects of special interest are typically seen in a population as a result of COVID, Long COVID or incidental health problems. Refractive error, for instance, is common among adolescents but is listed here as a side effect of vaccination. Thus their conclusion that “nearly one-thirds of participants receiving the BBV152 vaccine reported adverse effects of special interest” is misleading, and most likely erroneous,” says Dr. Rajeev Jayadevan, co-chairman of the National IMA COVID task Force.

Dismissing Dr. Patwardhan’s argument that a control group may not be necessary in a longitudinal observational study, Dr. Menon says: “If the question, as here, is the possibility of adverse effects following vaccination, it is a question about causality. To answer these, it is important to remove as many confounders as possible, such as the possibility that some fraction of participants were infected by the virus prior to or after vaccination. If, in a normal non-COVID year, an equally substantial fraction of people were afflicted by upper respiratory tract infections, that would certainly be relevant to asking if the vaccine was [indeed] responsible for the AESIs picked up by this survey.”

Objecting to Dr. Patwardhan’s claim made in a tweet that the “goal [of the longitudinal study] is often to observe natural progressions and associations rather than to establish direct causal relationships with the use of a control group”, Dr. Menon points out that the paper clearly states that “serious adverse events may occur in 1% of BBV152 [Covaxin] recipients”, which is a statement of specific causality. The only robust way of linking the administration of the vaccine to a specific set of adverse effects is to have an appropriate control group, stresses Dr. Menon. Dr. Vashishtha too says that it is difficult to conclude natural progression without comparing it with the control arm.

The second most critical limitation of the study is the failure to test the participants for SARS-CoV-2 infection/COVID-19 disease and associating all the adverse events solely to vaccination. Since the study lasted from January 2022 to August 2023, the chances that the participants were truly uninfected and all adverse events seen were only due to vaccination are slim. “Serological studies in Uttar Pradesh [where the participants lived] after the Delta wave point to over 80% of the population having been infected. Some of the AESIs in question could have been a consequence of an initial SARS-CoV-2 infection and not the vaccination,” says Dr. Menon.

Worse is when the researchers claim some of deaths to be “possibly” associated with Covaxin even when infection/disease was not ruled out through testing or taking into account pre-existing conditions/diseases such as hypertension and diabetes. The researchers have followed the WHO classification for AEFI categories, and one of WHO’s AEFI categories is coincidental reaction/event. “These deaths possibly belong to this category,” says Dr. Vashishtha. They failed to provide substantial evidence on the causal association of some of the serious adverse events like Guillain-Barre syndrome (GBS). The only subject with this neurological condition had a history of GBS. Most of the instances mentioned by the authors can merely be termed as coincidental.”

“The same group of investigators had studied the Covishield vaccine using an almost similar methodology. They found that Covishield had led to AESIs in 14%, whereas Covaxin led to AESIs in one-third of the participants of the trial. This defies logic. Globally, inactivated vaccines are considered safer than Adenovirus vector-based vaccines,” adds Dr. Vashishtha.

The third major limitation is that the observational study was conducted over telephone and participants were asked to recall persistent AESIs (lasting for at least one month) at the end of the one year follow-up. The design of the study did not include direct interaction with participants and clinical evaluation of the AESIs though the study was done well past the dangerous phase of the pandemic. “On a pedestal of quality of evidence generated by types of studies, the observational studies lie at the lowest rung, just above the case reports and personal experiences,” says Dr. Vashishtha.

If evidence collected from observational studies per se does not rank high, relying solely on telephone interaction with participants one year after vaccination further dents the study. “Physical follow-up is costly and as a first step, substituting this by a telephone survey can be acceptable. But this said, it’s certainly not a preferred choice in cases such as these. And without a comparator non-vaccinated group being asked the same questions, this exercise cannot be really trusted,” says Dr. Menon. “Furthermore, it relies on recall over a long period, rather than any independent quantitative measure, and this can be inaccurate. Such inaccuracy can go both ways, in terms of both exaggerating an effect or minimising it, since memories, especially over long periods, can be untrustworthy.”

The researchers recruited 1,024 individuals (635 adolescents and 291 adults) to assess the safety of Covaxin at the end of one year following vaccination. On the merit of including a small number of participants for the study, Dr. Menon says: “Whether the number of participants is small or large can only be answered with some prior idea of whether the effect that is being investigated is a large effect or a small one. Worldwide, there is consensus that long-term adverse effects arising solely out of vaccinations are rare. One must therefore go to very large samples in what is called a phase-4 clinical trial. The numbers included in the BHU study are too small for definitive statements to be made.” The paper notes that the “sample size was decided based on the primary outcome of AEFIs and not based on AESIs.



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Top Medical Body Slams Study On Covaxin Safety, Side-Effects, Wants Apology https://artifexnews.net/covaxin-safety-benares-hindu-university-icmr-top-medical-body-slams-study-on-covaxin-safety-side-effects-wants-apology-5704823rand29/ Mon, 20 May 2024 10:13:30 +0000 https://artifexnews.net/covaxin-safety-benares-hindu-university-icmr-top-medical-body-slams-study-on-covaxin-safety-side-effects-wants-apology-5704823rand29/ Read More “Top Medical Body Slams Study On Covaxin Safety, Side-Effects, Wants Apology” »

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Bharat Biotech’s Covaxin was one of two Covid-19 vaccines available in India (File).

New Delhi:

The Indian Council of Medical Research, or ICMR, has distanced itself from a follow-up study by two Banaras Hindu University professors that said nearly a third of 926 individuals who received the India-made Covaxin COVID-19 vaccine reported serious side-effects.

The study claimed that around one per cent of respondents reported strokes and an autoimmune disorder called Guillain-Barre Syndrome, which causes weakness in nerves in the arms and legs.

Conducted between January 2022 and August 2023, the study also said 50 per cent of the sample size complained of respiratory infections, and over 30 per cent reported assorted physical problems, ranging from skin and nervous system disorders to bone and muscle problems.

READ | Over 30% Covaxin Takers Had Health Issues After Year: Study

Specifically, between adolescents and adults respondents the study claimed 10.5 per cent reported new-onset skin and subcutaneous disorders and 10.2 per cent claimed nervous system concerns.

Among female respondents, 4.6 per cent claimed menstrual disorders.

ICMR Criticises Study Flagging Covaxin AESIs

However, the ICMR faulted the study – ‘Long-Term Safety Analysis of BBVl52 Coronavirus Vaccine in Adolescents and Adults: Findings From a 1-Year Prospective Study in North India’ published by Springer Nature – for poor methodology, and objected to it “acknowledging” the medical body.

ICMR Director-General Rajiv Bahl said the study had no control arm (of unvaccinated individuals) to compare rate of AESIs, or Adverse Events of Special Interest, and, therefore, the reported side-effects could not be linked or attributed to being administered Covaxin as COVID-19 vaccination.

Continuing a long list of critical observations, the ICMR boss also declared the study does not provide background rates of observed events in the population, making it impossible to assess change in such incidences in the post-vaccination period.

FACT CHECK | Can Covaxin Lead To Death After 2 Years Of Vaccination?

The method of data collection – study participants were contacted via telephone a year after vaccination and their responses were recorded without confirming them via medical records or examination by doctors – was also severely criticised.

Dr Bahl stressed that the ICMR is not associated with the study claiming side-effects from the India-developed vaccine, and had not provided any support – technical or financial – to the study authors.

The study authors and publishers have been urged to remove the acknowledgement to the ICMR.

“The authors are urged to rectify acknowledgment to ICMR and publish an erratum. Additionally, they are asked to address methodological concerns raised,” the ICMR chief said.

“Failure to do so may prompt ICMR to consider legal and administrative action.”

What Study Authors Said

Among the points made, the researchers acknowledged that understanding the AESIs-vaccines link required a control arm of unvaccinated individuals to compare rates of reported serious side-effects.

The authors also said that in the absence of data on background rates of observed AESIs, no comments were possible on changes in incidence of observed events in post-vaccination periods.

“Our findings are confined to BBV152 (Covaxin) and should not be extrapolated to viral vector or mRNA vaccines. The study primarily involved adolescents and the sample size of adults was relatively small. Larger adult-based studies are needed to understand long-term safety of BBV152 in adults.”

Bharat Biotech Responds

The study has also been questioned by Covaxin developers and manufacturers Bharat Biotech, which pointed to multiple alternate studies to emphasise its drug’s “excellent safety track record”.

READ | Bharat Biotech Flags Covaxin’s Excellent Safety Record In Risks Row

The ICMR’s strong reaction to the study comes amid concern over potentially fatal side-effects for those who received the vaccine developed by British pharma giant AstraZeneca and Oxford University, and manufactured and sold in India – as Covishield – by the Serum Institute.

Concerns Over Covishield

Given the questions about Covishield and Covaxin’s long-term safety records, a group of doctors last week called for a review all the science behind all Covid vaccines, as well implementation of surveillance and monitoring measures to ensure vaccine AESIs are identified as early as possible.

READ | Covishield Safety Row: Doctors Urge Centre To Review All Vaccines

The spotlight, so far, has been squarely on Covishield after AstraZeneca was hit by multiple lawsuits in the United Kingdom, with at least one patient claiming he suffered a serious brain injury following a blood clot that formed after he was injected in April 2021.

Fact Check | Are Indians Who Got Covishield Vaccine Susceptible To TTS?

AstraZeneca initially contested the claim but later said its vaccine could “in very rare cases” cause Thrombosis with Thrombocytopenia Syndrome, or TTS, which is a medical condition that can cause blood clots and low platelet counts, and has been linked to over 80 deaths in the UK alone.

READ | AstraZeneca Drops Covid Vaccine After Rare Side Effect Report

The company has expressed sympathy for those who have lost loved ones or reported health problems, but has reiterated its commitment to patient safety and adherence to “stringent (safety) standards”

It has also announced a global withdrawal of all vaccine stock, but attributed the withdrawal to commercial reasons, i.e., to a “surplus of available updated vaccines” for COVID-19.

Vaccinations In India

As of this morning, approximately 17 per cent of all vaccines administered were Covaxin, according to data from the government’s CoWIN dashboard.

https://dashboard.cowin.gov.in/

Photo Credit: https://dashboard.cowin.gov.in/

The overwhelming majority of the population received the Covishield vaccine, while a small section got the Corbevac jab.

Serum Institute On Covishield

The SII told NDTV that all its product packaging had “disclosed all rare to very rare side-effects”, including TTS, and pointed out the vaccine had been “instrumental” in saving lives worldwide.

READ | “We Disclosed All Rare Side-Effects”: Covid Vaccine Maker On Safety Row

The company also said it discontinued Covishield manufacture from 2021 due to “the emergence of new mutant variant strains”, which had led to decreased demand for previous vaccines”.

NDTV is now available on WhatsApp channels. Click on the link to get all the latest updates from NDTV on your chat.



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Can Covaxin Lead To Death After 2 Years Of Vaccination? https://artifexnews.net/fact-check-can-covaxin-lead-to-death-after-2-years-of-vaccination-5690843rand29/ Sat, 18 May 2024 08:50:05 +0000 https://artifexnews.net/fact-check-can-covaxin-lead-to-death-after-2-years-of-vaccination-5690843rand29/ Read More “Can Covaxin Lead To Death After 2 Years Of Vaccination?” »

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Quick Take

As per a social media user, Covaxin COVID vaccine can cause death after two years of vaccination. The user also claims that the Covaxin has caused the deaths of crores of people. We did the fact check and it came out to be false.

The claim

An X user has shared a post which claims Covaxin COVID vaccine has caused the death of crores of people across India.

Latest and Breaking News on NDTV

Fact Check

Is it true that Covaxin can cause death even after two years of vaccination?

No, Covaxin COVID vaccine cannot cause death two years after vaccination. As of the latest available information, there is no conclusive evidence linking Covaxin, developed by Bharat Biotech, to an increased risk of heart attacks or death occurring two years post-vaccination. Vaccines, including Covaxin, undergo rigorous testing for safety and efficacy before approval and continued monitoring even after approval. 

Some adverse events following vaccination can occur. But, these are generally observed within a short period after vaccination, and long-term severe side effects are extremely rare. Covaxin was approved for emergency use by the WHO, after a complete risk-benefit analysis. Moreover, vaccines are the most important tool in the fight against any disease. We must also remember we were combating a pandemic at that time. As we have stated it earlier, vaccines have saved lives and have helped in controlling the spread of disease.

It’s important to consider that heart attacks and other cardiovascular events can occur due to a variety of factors, such as underlying health conditions, lifestyle, and genetic predispositions. These events happening two years post-vaccination are unlikely to be directly related to the vaccine itself.

Were there clinical trials of the Covaxin?

Yes, Covaxin COVID vaccine underwent extensive clinical trials. In June 2020, the Ministry of Health and Family Welfare in India gave permission to start Phase I and II human trials for Covaxin after preclinical studies showed it was safe and produced a strong immune response in animals. Bharat Biotech conducted Phase I and Phase II trials involving approximately 1,000 participants. These trials demonstrated promising safety and immunogenicity results and were published in internationalpeer-reviewed scientific journals. Following these initial phases, the Phase III clinical trials for Covaxin began in mid-November, targeting the recruitment of 26,000 volunteers across multiple sites in India. This was the largest Phase III efficacy trial ever conducted for any vaccine in India, marking India’s first and only Phase III efficacy study for a COVID-19 vaccine. The trials ensure the vaccine’s safety and efficacy before approval and widespread distribution.

What regulatory approvals has Covaxin received?

Covaxin has received several significant regulatory approvals to ensure safety:

  1. India: The Drugs Controller General of India (DCGI) granted conditional market authorization for Covaxin COVID vaccine in January 2022. This approval followed the recommendation of the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) to upgrade the vaccine’s status from restricted emergency use, which had been granted in January 2021. The CDSCO also approved its sale or distribution for restricted use in emergencies of public concern.
  2. World Health Organization (WHO): Covaxin received emergency use approval from the WHO in November 2021. However, in April 2022, the WHO suspended the vaccine’s supply through UN procurement agencies due to deficiencies in implementing good manufacturing practices (GMP). Bharat Biotech responded by suspending the production of Covaxin for export to address these concerns.
  3. United States: In December 2020, Bharat Biotech partnered with US-based biopharmaceutical company Ocugen to collaborate on the clinical development, registration, and commercialization of Covaxin for the US market. In February 2022, the US Food and Drug Administration (FDA) lifted a clinical hold on Covaxin, allowing Phase II/III clinical trials to proceed in support of a biologics licence application (BLA) submission. However, in March 2022, the FDA declined to issue an emergency use authorization (EUA) for Covaxin for paediatric patients aged 2 to 18 years. Ocugen holds commercialization rights for Covaxin in North America and expanded these rights to include Mexico in April 2022.
  4. Other Countries: Covaxin has received emergency use authorization for adults in Mexico and is approved for emergency use in 20 other countries. Covaxin is licensed for use in 23 countries worldwide, although its distribution is predominantly within India, where over 77 million doses have been administered as of June 2022.

Why did the WHO suspend Covaxin’s supply?

The World Health Organization (WHO) stopped Covaxin supply for UN programs. This was because Bharat Biotech’s main manufacturing facility in Hyderabad didn’t fully follow good manufacturing practices (GMP). This happened because the facility had to focus entirely on making Covaxin due to the COVID-19 emergency. During this time, certain equipment needed for strict quality control wasn’t available due to the pandemic. Bharat Biotech emphasised that Covaxin’s quality was never compromised. 

Furthermore, WHO has also mentioned that this does not raise concern over the safety and efficacy of the Covaxin. It remains safe and effective.

How does Covaxin work?

Covaxin is an inactivated vaccine developed from the SARS-CoV-2 virus, meaning it uses a virus that has been killed and cannot cause COVID-19. When you receive the Covaxin shot, your immune system recognizes the inactivated virus and produces antibodies against it. These antibodies help your body fight off the virus if you are exposed to it in the future. The vaccine also includes substances called adjuvants, which enhance the immune response and help provide longer-lasting immunity. Covaxin is easy to store, as it only needs refrigeration between 2℃ to 8°C.

How effective is Covaxin?

Covaxin has been shown to be 77.8% effective against symptomatic COVID-19 according to the final analysis of its Phase III trials. A booster dose six months after the second dose resulted in over 75% of participants having detectable neutralising antibodies, with even higher antibody levels than after the initial two doses. The booster also showed strong responses against the Omicron and Delta variants. Side effects are generally mild, including pain at the injection site and flu-like symptoms. Covaxin has also demonstrated strong safety and efficacy in children compared to adults.

What are the side effects of Covaxin?

Covaxin may cause mild side effects such as pain, swelling, redness, or itching at the injection site, as well as body ache, weakness, stiffness, nausea, vomiting, fever, malaise, and headache. These effects are typically temporary and resolve on their own.

However, severe side effects or consequences of Covaxin are rare but can include allergic reactions such as anaphylaxis. It’s crucial to seek immediate medical attention if you experience symptoms like difficulty in breathing, swelling of the face or throat, rapid heartbeat, or severe dizziness after vaccination. Additionally, while extremely rare, there have been reports of blood clotting disorders associated with Covaxin.

How long does it take for a side effect to occur after vaccination?

After vaccination, most people experience a sore arm, with more widespread effects like fever and chills usually appearing within 8 to 12 hours. These side effects usually resolve within 48 hours. Since the vaccine cannot cause a COVID-19 infection, experiencing symptoms indicates a healthy immune response. While rare, allergic reactions can occur within the first 15 to 30 minutes after the jab. More common side effects include arm soreness, redness, and swelling at the injection site, with body-wide effects lasting 12 hours or more. Experts advise that these side effects generally cease within 24 to 48 hours after vaccination, although slight fatigue or arm soreness may persist. Comparing 48 hours of side effects to the risk of hospitalisation and death from COVID-19, experts emphasise the benefits of vaccination outweigh potential side effects.

What was the reaction of the medical community regarding Covaxin’s approval?

The emergency approval of Covaxin before completing Phase III trials faced criticism from the Indian scientific community. Despite nearly 14 million COVID-19 cases, approval came as cases were dropping. The CDSCO’s vague term “restricted use in an emergency situation” left many puzzled. 

Groups like the All India People’s Science Network called the approval “hasty,” while the All India Drug Action Network demanded transparency. Concerns grew after a Phase III trial participant died, with allegations of improper screening at the trial site.

However, 45 doctors, including former AIIMS directors, defended Covaxin, calling it India’s “gift to humanity” and labelling the criticism as “irresponsible.”

What should you do in case you have concerns regarding vaccines?

If you have specific concerns about health conditions post-vaccination, it’s advisable to consult with a healthcare professional. They can provide personalised medical advice and conduct any necessary evaluations. They can also help differentiate between vaccine-related issues and other potential causes of health problems. We would like to make it clear, one should not trust random and unreliable social media posts for making their healthcare decisions.

Are the authorities watching for heart problems after COVID-19 vaccines?

Yes, the CDC and other notable organisations have been actively monitoring COVID-19 vaccine-induced myocarditis. They provide transparent, evidence-based information on vaccine safety and participate in the WHO-led Vaccine Safety Net project. The CDC has launched investigations into myocarditis and pericarditis cases. Especially following mRNA vaccinations (Covaxin is an inactivated virus vaccine), with active surveillance in adolescents and young adults.

How does the CDC fight COVID-19 vaccine misinformation?

The CDC actively combats COVID-19 misinformation. To address false information on social media, the CDC uses a multimodal approach. It provides credible, evidence-based information on vaccine safety and adverse effects through its website and collaborates with health organizations. The CDC also uses social media to communicate with the public and dispel myths about COVID-19 vaccines.

We would like to conclude with, “The benefits of COVID vaccines far outweigh the associated side effects.

We have debunked several claims regarding the COVID vaccines. Was COVID handling by the Government of India a huge scam?Has Japan’s government banned the COVID-19 vaccine? Has the German government admitted there was no Pandemic?Has Japan declared an emergency over the ‘explosion of mRNA cancers’?Are Covishield-vaccinated Indians susceptible to developing TTS?

(This story was originally published by THIP Media, and republished by NDTV as part of the Shakti Collective.)

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



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