The second wave of Covid-19 infections has introduced India’s healthcare infrastructure to its knees. An unprecedented surge in circumstances coupled with a sluggish inoculation train makes it amply clear that the pandemic is way from over. More than 200 years for the reason that world’s first vaccine — for smallpox — was developed in 1796, vaccination for Covid-19 is now the highest precedence of all nations.
At current, two vaccines — Covishield and Covaxin — are being produced in India. Covishield (developed by the European firm Astrazeneca and University of Oxford) by Pune-based Serum Institute (SII) and the indigenous Covaxin by Hyderabad-based Bharat Biotech. While Serum Institute is producing the majority of the vaccines being administered in India, Bharat Biotech can also be wanting to ramp up manufacturing by establishing items in Pune, Bangalore and Bhubaneswar.
Even pharma large Dr Reddy’s Laboratories is exploring choices to manufacture Russian Sputnik V vaccine in India.
Covaxin, the indigenous coronavirus vaccine, can solely be produced in a BSL-3 (Biosafety Level) lab, stated Dr VK Paul. A member of the NITI Aayog (well being), Dr Paul can also be the chairman of the National Expert Group on Vaccine Administration for Covid-19 (NEGVAC).
File picture of Bharat Biotech’s excessive tech facility in Hyderabad the place dwell viruses are inactivated for vaccine manufacturing (Photo Credit: GettyImages)
Addressing a press convention on May 13, Dr VK Paul stated work on inactivated virus technology can only be done in a BSL-3 lab. “Not every company has this kind of sophisticated technology,” he added.
“There are two-three laboratories in every state. Let them make it [vaccine] not as a service, but with 10 per cent royalty, it can be done in 15-20 days,” stated Union Minister Nitin Gadkari on May 18.
Referring to the inadequacy of jabs to gas the world’s largest vaccination drive, the one at present underway in India, Gadkari added, “If the demand for vaccine is more than the supply, it creates the problem. So, instead of one company, let 10 more companies be given the license to manufacture the vaccine.”
What does BSL imply?
The time period BSL refers to Biological Safety Levels. Laboratories the world over engaged in biomedical analysis are categorised into 4 ranges starting from BSL-1 to BSL-4. This is finished to guarantee safeguards to defend lab personnel in addition to the environment from harmful pathogens which might be studied at these labs.
The US Centers for Disease Control and Prevention (CDC) determines Biosafety Label of a lab relying on the character of the organisms being researched or labored on at that individual facility.
File picture of a coronavirus detection lab in central China’s Hubei province (Photo Credits: AP)
For instance, analysis on nonlethal brokers or low-risk microbes might be carried out at a BSL-1 lab whereas coping with doubtlessly lethal infectious brokers comparable to Ebola requires a BSL-4 lab.
Research on pathogens or infectious organisms related to human ailments is carried out in BSL-2 labs. Similarly, labs categorised BSL-3 cope with microbes which might be both indigenous or unique.
Why is BSL-3 lab essential to Covaxin manufacturing?
Public coverage and well being techniques knowledgeable Chandrakant Lahariya advised India Today, “Covaxin contains an inactivated or dead virus. As part of the manufacturing of Covaxin through standardised processes, the live SARS-CoV-2 virus has to be inactivated. The handling of any live virus requires a BSL-3 level or higher facility. Therefore, any vaccine manufacturer which plans to manufacture Covaxin needs to have a BSL-3 facility.”
Dr V Ravi of The National Institute of Mental Health and Neuro-Sciences says, “Production of Covaxin requires biosafety level three as it can cause laboratory infections when it is grown in a BSL-2 facility. International safety guidelines require that SARS-CoV-2 needs to be handled in BSL-3 facilities. All vaccine manufacturers in India who produce rabies vaccines have BSL-3 facilities.”
File picture of Rota Virus vaccines being produced at Bharat Biotech’s excessive tech facility in Hyderabad (Photo Credits: Getty Images)
“Currently, Bharat Biotech is expanding its manufacturing in Europe apart from several other vaccine companies that have BSL-3 facilities, including those in the government sector. Further, it is setting up a huge plant at Malur in Karnataka. This plant will be operational in the next three months and has a huge capacity to make vaccines. SARS-CoV-2 needs to be first grown in cell cultures as a live virus before it is concentrated, purified and inactivated and can be utilised to produce a vaccine ready for human use,” Dr Ravi provides.
Risks concerned with BSL labs
Each employee in a BSL-1 lab is required to adhere to fundamental security procedures often called ‘normal microbial practices’. The use of PPE (Personal Protective Equipment) is a should even in a BSL-1 laboratory.
Research in BSL-2 labs usually requires contact with moderate-risk toxins that may trigger hurt if unintentionally inhaled or uncovered to the pores and skin. This is why washing sinks, eye-washing stations and doorways that shut and lock robotically are a should for BSL-2 laboratories. One may also discover an incinerator, used for decontamination and disposal of lab waste at these labs.
Most procedures in a BSL-2 lab are carried out inside a organic security cupboard (BSC). Workers are additionally required to put on PPE kits, eye safety and face shields.
File picture of researchers testing coronavirus samples in a virology lab at San Matteo Hospital in Pavia, northern Italy (Photo Credits: AP)
In a BSL-3 lab, all experiments are carried out in a biosafety cupboard to keep away from publicity within the case of spills. Since these labs cope with infectious brokers which may be transmitted by means of the air, air flow inside a BSL-3 lab is managed through a filtered air flow system. Windows, flooring and partitions inside a BSL-3 lab are additionally sealed for this purpose.
A BSL-4 lab, which is on the prime of the biosafety degree tier, is often positioned in distant areas to guarantee a secure distance between the power and human settlements.
Interestingly, the Wuhan Institute of Virology lab in China, which is on the centre of a raging controversy over the origin of the SARS-CoV-2 virus, homes a BSL-4 laboratory.
File picture of the Wuhan Institute of Virology in China which homes the controversial BSL-4 lab (Photo Credits: AP)
It is vital to be aware that safeguards prescribed for every Biological Safety Level (BSL) construct on these prescribed for the earlier one. This signifies that a BSL-4 lab has all the protection measures present in a BSL-1, BSL-2, BSL-3 lab and more.
In India, the method to arrange BSL labs is reviewed by the Ministry of Science and Technology’s Department of Biotechnology and falls underneath the purview of the Indian Environment (Protection) Act of 1986. This laws was enacted underneath Article 253 of the Constitution within the wake of the 1984 Bhopal Gas Tragedy.
The highest security degree
There are no less than 44 notified BSL-4 labs around the globe, together with the Microbial Containment Complex on the National Institute of Virology (NIV) in Pune, Maharashtra. India has just one BSL-4 lab, the one at NIV, which was accredited in 2012.
Accredited one yr after the primary few circumstances of Crimean Congo haemorrhagic fever (CCHF) have been present in India, the BSL-4 lab was used to conduct molecular evolution research to examine whether or not the circumstances resulted from a bioterrorist assault.
File picture of The National Institute of Virology in Pune which homes India’s solely BSL-4 lab (Photo Credits: Getty Images)
In addition to coping with dangerous pathogens such as Nipah and SARS, the BSL-4 lab in Pune has earned excessive reward for its intensive work on the Crimean Congo haemorrhagic fever (CCHF) and Kyanasur Forest illness. The lab in Pune can also be the place a ‘one-minute technique’ to inactivate a dwell virus was developed.
The High Security Animal Disease Laboratory on the National Institute of High Security Animal Diseases (NIHSAD) in Bhopal, Madhya Pradesh, can also be a BSL-3+ lab. A BSL-3+ lab is a biosafety laboratory that exceeds the WHO’s minimal necessities for BSL-3 certification however is just not fairly BSL-4.
Around the world
The US had no less than ten operational BSL-4 services as of December 2017, in accordance to the World Health Organisation (WHO). There are additionally no less than 200 BSL-3 labs within the United States of America alone.
Jolted by the 2003 SARS epidemic, China dedicated itself to the event of a main community of high-level biosafety laboratories at totally different ranges. In 2019, the Chinese even constructed their first abroad BSL-3 lab in Sierra Leone. China intends to construct 5 to seven high-containment labs by 2025.
File picture of a researcher carrying coronavirus take a look at samples inside a BSL-3 lab in Shijiazhuang in China’s Hebei Province (Photo Credits: AP)
The European Union (EU), alternatively, collectively accounts for seven internationally acknowledged BSL-4 labs in 5 nations — UK, Germany, Sweden, Italy and France.
There are two varieties of BSL-4 labs. The first are cupboard laboratories the place all experiments are completed in a Class-III biosafety cupboard.
Then there are go well with laboratories the place lab personnel put on air-supplied fits, probably the most superior type of PPE, always. In these labs, it’s obligatory for all personnel to bathe and undergo a sequence of decontamination procedures earlier than exiting the laboratory.
- Inactivating dwell viruses for vaccine manufacturing can solely be completed at a BSL-3 lab.
- More BSL-3 labs will enable India to precisely peg the size and scope of any future pandemics.
- Compared to different growing nations, India has only a few BSL-3 labs and even fewer BSL-4 labs.
Vaccines are the world’s greatest hope within the fierce battle towards the novel coronavirus pandemic, a battle that’s being fought in every state and union territory in India on at the present time.
Paucity of BSL-3 and BSL-4 labs cannot solely hinder India’s probabilities of defeating this disaster but additionally go away the nation unguarded towards future pandemics.