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Vaccine expiry: Shelf-life extension of old vaccine batches ‘unethical’ and ‘alarming’, say scientists

Health activists demand the government to make Stability Study data public. Sources in the Central Drugs Standard Control Organisation (CDSCO) confirm to The Probe that reports related to stability studies on the shelf life extension given to Covaxin will not be made public

By Prema Sridevi
New Update

Vaccine expiry Photo courtesy: Special arrangement

After numerous media reports emerged on how children between the ages 15 and 18 were being administered expired Covaxin doses, the Ministry of Health and Family Welfare issued a press release on January 3.

The statement titled ‘Covid-19: Myth vs Facts’ refuted media reports that expired vaccines were being administered in India. Terming these reports ‘ false and misleading’, the ministry said that India’s national regulatory body Central Drugs Standard Control Organisation (CDSCO), had earlier approved the extension of the shelf life of Covaxin and Covishield vaccines to 12 months and 9 months, respectively.

The press release stated: “The Central Drugs Standard Control Organisation on October 25 2021, in response to M/s Bharat Biotech International Limited’s letter no: BBIL/RA/21/567 has approved the extension of the shelf life of Covaxin (Whole Virion, Inactivated Coronavirus Vaccine) from 9 months to 12 months. Similarly, the shelf life of Covishield has been extended by the National Regulator from 6 months to 9 months on February 22 2021.”

The ministry also noted in its statement that the shelf-life of the vaccines was extended by the National Regulator based on comprehensive analysis and examination of stability study data furnished by the vaccine manufacturers. But the procedures adopted by the government for extension of the shelf-life of the vaccines has evoked criticism from scientists, health activists and vaccine dose recipients from across the country.

Gauri Thakur, a resident of Delhi-NCR speaks about expired vaccines | Video courtesy: The Probe team

From January 3, the government opened up vaccinations for children aged 15 to 18 years. The Probe spoke to many children who received the jabs and their parents. Many of them expressed concerns over expired vaccines being administered to them. "They have increased the date after the products have expired. This isn't good. They shouldn't have done this. They are increasing the expiry on the file, but the product is the same old one. They shouldn't have done this," said Gauri Thakur, a resident of Delhi-NCR.

While it is not uncommon for the government to increase the shelf-life of a vaccine based on scientific study, many scientists say due procedures were not followed by the government while approving the extension of the vaccine expiry.

Vaccine expiry Covaxin being administered to 15-18 year old children at a centre in Noida | Photo courtesy: The Probe team

"It is not uncommon for a national regulator to extend the expiry of the vaccines. But the question is how can the shelf-life extension be given to old vaccine batches. This is alarming. As far as I know, no country has extended the shelf-life of vaccines of old batches as a retrograde process. There are huge health implications to this," said Dr S Krishnaswamy, a scientist and retired professor at the Madurai Kamaraj University.

The 'vaccine expiry' controversy erupted after parents took to Twitter after discovering that their children were being administered expired doses. Gurugram resident Navanita Varadpande said in a tweet: "So my son went to get his first vaccine, the drive for kids began today and realised that the vaccine had already expired in November. Then a letter was shown wherein it seems the shelf life has been extended! How, why, on what basis? To clear the stock, you experiment on kids?"

Even when the government claimed in their press statement that they had approved the extension of the shelf-life of Covaxin from 9 months to 12 months in October itself, many healthcare workers in health centres visited by The Probe claimed that they did not receive communication from the government regarding this.

“Many of our vaccine batches expired, and there was much confusion over what had to be done to the expired doses. Since we did not hear from the government in October or November last year on the extension of shelf-life, many of us did not continue to store these vaccines under the stipulated conditions because we thought they could be disposed of as they were no longer safe to use. If we had known that the vaccine expiry was extended, then we would have continued to store the vaccines under appropriate conditions. The problem with increasing the shelf-life of old batches is that many like us may not have stored the vaccines properly. If such vaccines are administered to people, they will not benefit from the jabs. This has huge health implications as well,” said a government healthcare professional from Gautam Buddha Nagar in Uttar Pradesh on condition of anonymity.

Gunjan Chauhan, a 17-year-old vaccine recipient speaks to The Probe | Video courtesy: The Probe team

The CDSCO had initially given permission for the sale of Covaxin with a shelf-life of 6 months if the vaccine was stored at 2 to 8 degrees celsius. The healthcare professionals who administered the vaccines pointed us to Bharat Biotech's website that mentions, “The expiry date of Covaxin is indicated on the label and carton of the vaccine. Do not use the vaccine after the expiration date shown on the label and carton of the vaccine.”

“When Bharat Biotech has made it clear that expired vaccines should not be used, then why would we continue to store the vaccines under the prescribed temperatures? The point here is that it was only after this entire controversy started that the company in question made attempts to call back the unused stocks of Covaxin and update the expiry date on the labels. Now there is vaccine hesitancy amongst people because of this confusion,” said another government doctor from Delhi on condition of anonymity.

Bharat Biotech on guidelines Bharat Biotech on guidelines related to the storage and use of Covaxin

“I feel safe after getting the vaccine. But I believe that we should not use products after the expiry. If we buy a product that is expired and if we use it, it will harm us,” said Gunjan Chauhan, a 17-year-old who received her first jab of Covaxin this month in Noida.

The shelf-life of a vaccine is a reflection of how long the vaccine retains its potency and stability at a given storage temperature and, therefore, its effectiveness. While the expiry dates do not affect the safety of the vaccine, it has a direct impact on the potency or the amount of protection the vaccine gives.

In a statement issued by the World Health Organisation on May 17 last year on the expiry date and shelf life of the AstraZeneca Covishield vaccine produced by the Serum Institute of India, the WHO states: “Any extension in the shelf-life will only apply to vaccines not yet labelled and distributed. Therefore, the expired or near to expire doses in distribution for use will not be affected by the future decision of shelf-life extension. This decision is expected to be communicated to all countries’ national regulatory authorities in due course.”

The question is, despite the communication, why did India’s national regulator decide to extend the shelf-life of old batches of vaccines instead of applying them on the new batches? Why were the vaccination sites not informed well in advance about what they had to do with the expired vaccines? In the absence of an awareness campaign or communication from the government on shelf-life extension, how can the government guarantee that the expired vaccines administered to the people were stored under the ideal conditions? Under what provisions of the rules did the regulator permit the extension to be applied from the current batch and not from the future batches? Was the re-labelling of the vaccine doses part of that requirement, and if so, why did the company wake up only now to do the re-labelling?

Usha Yadav, a healthcare worker speaks to The Probe on people expressing concerns over expired vaccine doses | Video courtesy: The Probe team

Speaking to The Probe, another healthcare worker Usha Yadav who has been administering expired vaccine doses to 15 to 18-year-olds, admitted that people have been anxious over getting jabs from old expired batches. “We feel very good that vaccination is happening for this age group. But some people are anxious about getting vaccines that have expired. But it’s not like that. They have increased the expiry dates. So, it is ok.”

While many agree that the regulator should have permitted the new expiry date to be placed on the subsequent batches that are manufactured post the approval and not the old batches, some have also called out the government for lack of transparency in sharing the data related to the stability studies.

“It is ok to increase the shelf-life or expiry of a drug based on stability studies and other research, but the larger point is anything related to technology affecting the lives of the people across the country must be put up in the public domain. There are enough experts outside the policy-making spectrum of the government who are competent to analyse the pros and cons. When data is made public, even international bodies look at it, and best policies and practises can be evolved. But unfortunately, the government of India doesn't like to put things in the public domain. We don’t have a culture of open debates and discussions. The way the government applied the extension of shelf-life to old vaccine batches without sharing any data is unethical to say the least,” said Chinu Srinivasan, Co-convenor of All India Drug Action Network (AIDAN).

Prashant Kumar Singh, a parent speaks to The Probe from a vaccination centre in Noida on expired vaccines | Video courtesy: The Probe team

In many states, the re-labelling of the Covaxin shots was delayed, and in some cases, recipients were given jabs with vials that still had the old labels. For instance, in Karnataka, there was confusion over the shelf-life of Covaxin because of which some private hospitals in the state decided to postpone the vaccination drive by a few days as they did not get the re-labelled vaccines from the company on time.

“The company was not proactive. They had an indifferent attitude. They should have done the re-labelling much before the vials expired. They should have picked it up at least 3 or 4 weeks before the expiry. They kept dragging their feet, and in the end, it was only picked up recently, sometimes towards the end of December. This has given rise to a lot of unnecessary confusion,” said Dr Prasanna H.M, President of Private Hospitals and Nursing Homes Association (Phana) in Bangalore.

Dr. Shashank Shekhar, another parent speaks to The Probe | Video courtesy: The Probe team

Despite mounting concerns, some other parents told The Probe that getting something was better than getting nothing at all. “We, as parents, were very anxious earlier that we got ourselves vaccinated, but our children couldn’t get the jabs. But now, when our kids are getting vaccinated, we feel relieved that our children can also be safe now,” said Dr Shashank Shekhar, who had accompanied his children to a vaccination centre in Noida.

Expressing hope that the government must have had the best interest of the people in mind, another parent, Prashant Kumar Singh, said, “I am sure they must have thought about it. So many scientists have worked on this. They know better. We don’t know much about it. They must have taken the correct decision. If the decision on vaccine expiry is wrong, it will reflect in the coming days”.

In July 2021, the World Health organisation had released guidelines on the effective utilisation of Covid-19 vaccines before the date of expiry. The guidelines enlisted a step-by-step approach to devise a framework by countries to support the planning and implementation of vaccination to ensure that the vaccine doses are optimally used before reaching their expiry date.

The report states that the countries must monitor data at the district level and report the utilisation levels to the centre on a daily basis to estimate the capacity to utilise vaccines before the expiry date. Monitoring the utilisation of vaccines must be done in a disciplined manner because that is the key to detecting and solving issues related to vaccine hesitancy and potency. But in India, most of the data related to vaccine utilisation, expired vaccines, and re-labelled vaccines are still not available in the public domain.

Ashutosh Garg, a Noida resident speaks to The Probe from a vaccination centre | Video courtesy: The Probe team

“It is not unusual to start with a sanction of shelf life of 6 months and then extend it to 1 year or one and a half years. That is not unusual. But we are worried about two things. The first thing is that we don’t have enough data on the public domain that has the reports based on which such a decision has been taken. The second thing is we don’t know whether the shelf-life is the same for vaccines that are at the periphery of the supply chain. For instance, when a drug is kept at the warehouse, it is warehoused in a certain ideal condition. Then when it is sent down the chain, it is taken out and put into ice-lined boxes and transported around refrigerators and then put into hospital facilities or other places under specified ideal conditions. So, we are unsure about whether these expired vaccines were actually stored in such ideal conditions,” said Dr Sundararaman, Health Coordinator, All India People’s Science Network (AIPSN).

Admitting that the government could have handled the situation differently, Dr Sundararaman said, “The fact is that they could have earned people’s trust by being more transparent about data and by increasing the shelf-life of only new batches post the approval so that at least we can be sure that the old vaccines or poorly stored and expired vaccines are not administered to the children”.

While it is important to extend the vaccine’s shelf life if there are adequate feasibility studies and stability data to show that the vaccine is safe if shelf-life is extended, the question is why was this done retrospectively. Although the extension of the expiry date avoids vaccine wastage, the point is why did the CDSCO not communicate the extension to all its stakeholders and launch awareness campaigns amongst the public to curb vaccine hesitancy. The first communication regarding this came from Bharat Biotech, while it should have come from the Ministry of Health. What measures did the government implement to ensure that the quality of the vaccines is maintained to the highest degree of standard before and after re-labelling the vials?

Sources in the Central Drugs Standard Control Organisation (CDSCO) have confirmed to The Probe that the data related to stability studies and other reports on the shelf-life extension given to Covaxin will not be made public. We are yet to get a response from Bharat Biotech on our queries related to the Stability Studies conducted by the company.

It is time for Bharat Biotech and the government to step in and release in the public domain all information pertaining to the stability studies and tests done that led to the extension of vaccine expiry dates. Corroborative evidence over mere claims is the need of the hour.

(This article will be updated once we get a response from Bharat Biotech)
(With video inputs from Sourav Rai and Sumeshwar Sonu)