Vaccine With Love

At dot 8.30 AM the main gates of Vaccines India Pvt. Ltd were thrown open as the company’s staff busses started arriving. The staff started getting off the buses and it was impossible to miss the palpable eagerness and sense of urgency in them to get to their work. Those from R&D division had to collect data from the experiments done overnight and submit to the bosses who would do the analyses and interpretation and design follow up experiments. Those from the manufacturing and Quality control (QC) Divisions, which work 24 x7 in three shifts had to relieve the colleague from previous shift and take over the duties. Of course, before that they had to quickly have breakfast. The company had developed a vaccine for COVID 19, which is under Clinical Trials. Every employ was thrilled to be contributing to this project in one way or the other and proud to be working in this company.

It was a sprawling site with an R&D block, several independent manufacturing units dedicated to different products, a Quality Control unit, administration block, Regulatory affairs and Clinical research block. A full-fledged canteen provided every meal making sure the staff was well fed while their families did not have to toil to provide them tiffin boxes!

Dr. Vinay and Dr. Sujatha also got off the bus, full of enthusiasm. They preferred to take the company bus though both were given company cars, to avoid long drive and as an added advantage, could take a nap during the bus journey! He was the Principal Scientist handling the COVID19 Vaccine project and she was given the responsibility of Quality control or testing of the Vaccine. Both were very young but already held critical positions in the company based on their competency. Both were in love and had plans of getting married soon. They were discreet about this and every one in the factory also reciprocated to this, though their love for each other was evident.

Vinay quickly waved bye to Sujatha and rushed towards his lab. The previous evening, he had set up an experiment to analyze the sequence of the vaccine protein from the 5th consecutive commercial scale batch and was eager to see the result. He went to the HPLC (High Performance Liquid Chromatography ) machine, quickly ran through the data on the computer and took out the printout. He was glad that superimposition of data from all five batches was showing perfect alignment, with expected size. His junior who was silently watching his boss, could not contain his curiosity. He asked , “ Sir, what is there to feel so happy about ? It is expected to match the previous batches, isn’t it? Vinay chuckled and said,” of course it is as expected but now we have proof in our hand. This data proves the consistency of the product and process.” 

He was little free and in good mood. As he continued, few other juniors quietly joined as they knew that Vinay would impart valuable knowledge.” Look we selected a Virus protein (antigen) suitable as vaccine candidate, constructed a recombinant microbial cell line capable of making/producing the Vaccine antigen, when it is grown under certain conditions. We developed a process for growing the microbial cells at commercial scale and purification process which involves getting rid of host materials like proteins, lipids and DNA and producing up to 95% pure vaccine antigen. At the same time we developed tests to demonstrate the removal of impurities and to show high level of purity of the Vaccine antigen. Some of these tests are going to be routine quality control tests that will be done on every batch of vaccine manufactured.

You know that we have already training Dr. Sujatha and her team on these tests and eventually they will be transferred to QC. The process for cell culture/growth and antigen purification (Manufacturing) is being transferred to the manufacturing department. We at R&D have shown the identity of the antigen and activity (functionality as antigen) in small animals and will continue to carry out a wide variety of tests to prove the purity of the protein. As you know, with the data in hand we were permitted by the Govt. agency to conduct safety studies in animals and are carrying out the human clinical trials. At the end of these studies all the data from the target identification to clinical trials will be compiled into a Dossier also known as the Drug Master File and submitted to Drug controlling authorities in India.

Our Clinical studies group is very busy now and Regulatory affairs group is gearing up to submit the Dossiers in India and in foreign countries for exports.” He said.” You see under normal circumstance this huge activity is done step by step sequentially but now in view of urgency to have vaccine to save time many things are done in parallel, making it very confusing to youngsters like you. Not to worry, we are there to clarify any doubts.

But remember, no short cuts are being taken and in fact we are carrying extensive studies to be very confident on the product. After all the safety of the Vaccine recipients is of utmost priority to us,” he concluded and had to rush to the QC lab as there was a call to analyze some data. All the Juniors there who were awe struck and lost in admiration for their boss, slowly came out of their thoughts and moved back to work.

 Vinay and Sujatha went over data in hand and could understand why the test failed this time and how to overcome. Both had lot of work and had no time to talk anything personal. Finalizing their marriage date and the related activities was lingering on their mind and they had no time to discuss about those issues even outside the work hours. Both were very well aware that they have been very fortunate to get this rare opportunity of participating in the Vaccine development and would not get diverted by anything.

Within no time, the Vaccine Clinical trials were completed and after all the approvals and formalities, the Vaccine was released into the market. Vinay and Sujatha were in the limelight along with few others from rest of the departments and were thoroughly enjoying the attention they received in the company. “Time to initiate the wedding plans!” both said aloud at the same time as they were having coffee in the canteen. They could not help but burst out into laughter. At the same time a Peon came to them with the message that they were being summoned at the Chairman’s office. Both were taken aback, gained their composure and walked towards the Chairman’s office, wondering what the reason could be.

The Chairman’s office was very simple yet elegant reflecting the nature of the occupant. He had his ways of being informed about important happenings in the lives of his key staff members. There were anecdotes on how he would some times surprise some of them. Presently Vinay and Sujatha were waiting for him to come and as soon as he entered, they got up from their seats. “Please sit down “there was seriousness in the tone and his face. “You are being ordered to proceed on personal leave from tomorrow” he showed two envelopes in front of them.

Both of them were confused and shocked not knowing the reason for what was unfolding. The Chairman continued to be serious for some time but looking at their pale faces, could not suppress his laughter. “Are you not going to open the envelops and see inside?” he said and let both open and read the letter inside. There was a special appreciation for their contribution to the COVID 19 Vaccine development and also a mention about how they set aside their marriage and gave priority to their work. Their direct bosses had passed on the information to the Chairman. ”I want you both to take off from tomorrow and make arrangements for your wedding . It is an order” Their thrill knew no bounds and they were on cloud 9 as they walked out of the office.