Covaxin, Bharat’s indigenous Covid-19 vaccine has finally received emergency use listing (EUL) from WHO (World Health Organization). The world health body has been dilly-dallying in granting approval for the vaccine developed by Bharat Biotech even as several countries including Australia have recognized Bharat’s Covaxin.
The EUL permission was granted on the recommendation of the technical advisory group (TAG) on November 3. It has taken 16 long weeks for the organization to approve Bharat’s indigenous vaccine. “The Technical Advisory Group, convened by WHO and made up of regulatory experts from around the world, has determined that the #Covaxin vaccine meets WHO standards for protection against #COVID19, that the benefit of the vaccine far outweighs risks & the vaccine can be used Earth globe Europe-Africa”, WHO said in a tweet.
It also pointed out that the vaccine had been reviewed by Strategic Advisory Group of Experts on Immunization (SAGE) that recommended use of the vaccine in two doses with a gap of four weeks between the doses for all age groups above 18. However, as far as administering the vaccine to pregnant women goes, WHO opined that available data was insufficient to assess vaccine safety or efficacy in pregnancy and studies are being planned in this area.
It appears that the global health organization had been purposely delaying approval for Covaxin since by its own admission, Bharat Biotech has already supplied all the required information sought by it. “Covaxin manufacturer, Bharat Biotech, has been submitting data to WHO on a rolling basis & submitted additional info at WHO’s request on 27 September. WHO experts are currently reviewing this info & if it addresses all questions raised, WHO assessment will be finalized next week”, says TFI.
It is pertinent to note that the agency had said that it could not “cut corners” to approve a domestically developed vaccine. However, the same body had approved Sinopharm Chinese vaccine for emergency use within just 10 days. It must also be noted that the emergency use listing (EUL) to Sinopharm was awarded merely on the basis of interim data.
Similarly, Pfizer was approved within 6 weeks although reports indicate that its trials were compromised. Pfizer has been bullying governments by making unreasonable demands including indemnity meaning one cannot sue the company in case of severe Covid vaccine side effects and neither can one claim damages in such cases.
Furthermore, the company controls donations which means Pfizer will decide how and where the vaccines can be donated. The company also retains the right to decide delivery dates and when and where legal action can be taken against it. As per Pfizer’s conditions, disputes are to be settled in secret arbitration courts.
The British Medical Journal (BMJ) published a report quoting Brook Jackson who was employed with Ventavia Research Group that was conducting the trials. Jackson had also complained to the US Food and Drug Administration (FDA) that had approved the vaccine. However, she got nothing more than an acknowledgement and a phone call. In stead of looking into the concerns, Ventavia fired Jackson two weeks after she raised the red flag against Pfizer vaccine trials.
Some of the concerns raised by Jackson as noted by the BMJ report are:
- Participants placed in a hallway after injection and not being monitored by clinical staff
- Lack of timely follow-up of patients who experienced adverse events
- Protocol deviations not being reported
- Vaccines not being stored at proper temperatures
- Mislabelled laboratory specimens, and
- Targeting of Ventavia staff for reporting these types of problems.
Despite such serious lapses, WHO seems to have cut corners to approve the Pfizer vaccine while deliberating delaying approval to Covaxin. Bharat Biotech Chairman Dr Krishna Ella has stated that the delay in WHO’s approval was due to the negative publicity that Bharat’s indigenous vaccine received from various corners.
“We have 5 vaccines WHO pre-qualified so we knew it very well, we know how to do it. But the problem is many media people who are negative, they even wrote to the scientific journals to look into some death in Bhopal. It happened because of suicide but it was blamed on vaccine”.
“The way anti-things happen, that has hurt us more. I want people to realise instead of criticising just ask us, we will tell the truth. But making own opinion that hurt us very badly – that got delayed, some of the process. Whether our publications got delayed or our WHO pre-qualification was delayed because they have to investigate a lot of things… We are very transparent, we are truthful and we won the game,” he added, stating how the negativity hurt various processes for Covaxin.
Anti-Bharat forces have time and again slandered Bharat’s indigenous vaccine in an attempt to discredit it.