Why Bharat Biotech’s Covaxin is not getting approval in highly regulated countries

India made COVID-19 vaccine, Covaxin manufactured by Bharat Biotech in collaboration with Indian Council of Medical Research  is been used extensively in most of the countries. However, the regulatory body of USA, USFDA has still not given the approval of usage of Covaxin on their citizens. It is believed that their regulatory body wants further clarification on the clinical trials conducted for Covaxin by Bharat Biotech.

What is the reason behind USFDA’s unapproval?

USFDA has asked Bharat Biotech to submit the clinical trial data of Covaxin so as to get the vaccine approval in United States. But after the submission of partial data of clinical trials of Covaxin, the regulatory body of USA rejected the approval and has asked Ocugen( Hyderabad based pharma company which is also Bharat Biotech’s US partner) to submit the additional trial data. Covaxin is therefore rejected for emergency use due to lack of scientific data according to US regulators. However,  if they get the complete trial data from Bharat Biotech they can file a Biologics License Application(BLA) seeking a full approval instead.

Recently, USFDA has revised their guidelines for emergency use authorization and stated that they won’t be entertaining further requests. After all this, Occugen remains hopeful for a good news.

Bharat Biotech’s delay to share Phase- 3 clinical trial data

Bharat Biotech has not yet shared the clinical trial data of phase 3 trials and are expected to share it on next month. Following which, the company will start applying for a full licensure of Covaxin. “Once data from the final analysis of phase III studies are available, Bharat Biotech will apply for full licensure for Covaxin,” Bharat Biotech told the news channels.

Further they added, they have already taken the data of Phase-4 clinical trials which is the post- marketing surveillance to check the safety and effectiveness of the vaccine.

Hurdles of Bharat Biotech’s Covaxin

COVID-19 vaccine, Covaxin manufactured by Bharat Biotech has been facing enormous hurdles in front of them pertaining to it’s approval. The wait of Phase 3 clinical trial data is taking long and that is the reason it is still not being validated by World Health Organization(WHO). Without which they are unable to export their vaccine and make an entry into the Covid 19  passport.   

Different countries has different regulations and also some of the them have stingent  regulations. Due to which COVID- 19 vaccine manufactured by Bharat Biotech, Covaxin remains unapproved in all those countries without their Phase 3 clinical trial data.  This is the reason why, foreign universities are also not considering students who has been vaccinated with Covaxin. They are considering them as “un-vaccinated” in this regard.

Now it remains to be seen how soon they can procure the clinical trial data of phase 3 and then they can get the approval from foreign countries for emergency use. Also, the approval from WHO is required to get into the coveted COVID-19 vaccine passport. “We are aware that Bharat Biotech has sought the WHO emergency-use listing for Covaxin. We hope that the process of getting this approval is completed at an early date,” said Ministry of External Affairs spokesperson, Arindam Bagchi on this issue.

Why physical exercise is so important

physical exercise is so important because it provides us with N number of benefits. There are some of the benefits that are being described below.

Improve your life longing

Numerous studies have shown that regular physical activity increases life yearning and reduces the risk of early mortality. There’s not a magic formula that translates hours of physical activity into hours of life increased, but research suggests that more effective people tend to be healthier and tend to live longer.

Lessen your risk of destruction

Regular exercise and physical activity increase muscle strength, bone density, flexibility, and stability. Physical fitness can reduce your risk for and strength to accidental injuries, especially as you get older. For example, stronger muscles and better balance mean that you’re less likely to slip and fall, and stronger bones mean that your less likely to undergo bone injuries should you take a fall.

Enhance your quality of life

An inactive lifestyle and a lack of physical activity can take a toll on a person’s body. Physical inactivity is associated with an increased risk for certain types of cancer, numerous chronic diseases, and mental health issues. Exercise, however, has been shown to improve mood and mental health and provides numerous health benefits. Of course, physical fitness also allows you to do things that you may not otherwise be able to do.

Stay effective

Staying effective and healthy allows you to do activities that require a certain level of physical fitness. For example, hiking to the top of a mountain is a rewarding experience that instils a sense of accomplishment and provides spectacular scenery, but some people cannot experience this due to fitness restrictions.

But even walking around a park with your family or playing on the playground with your children can be challenging for those who disregard physical activity for extended periods. Being active means that it’s easier to stay active as you get older.

Improve your health

There are various health advantages to physical fitness. Regular exercise and physical activity promote strong muscles and bones. It improves respiratory, cardiovascular health, and overall health. Staying active can also help you maintain a healthy weight, reduce your risk for type 2 diabetes, heart disease, and reduce your risk for some cancers.

In other words, staying effective is a significant part of conserving good health and wellness.

Gujarat: 7.97 lakh COVID patients recovered so far in state, 481 new cases recorded

Gujarat has recorded 481 new cases of COVID-19 yesterday. 1526 patients recovered during the last 24 hours and were discharged from the hospitals. AIR Ahmedabad correspondent reports that total 7 lakh 97 thousand 734 patients have been recovered from COVID-19 in Gujarat till now. The recovery rate further improved and reached up to 97.36 percent.

Maximum 69 new cases of COVID-19 reported from Ahmedabad, while Surat recorded 62 new cases. 9 patients lost their lives yesterday. Gujarat has now 11,657 active cases at present, out of which 296 patients are on ventilator. Meanwhile, 2 lakh 86 thousand 459 persons have been vaccinated in the state yesterday. With this, more than one crore 97 lakh persons have been vaccinated in Gujarat till now.

Himachal Pradesh: Corona Curfew extended till further orders with relaxations

Corona Curfew in Himachal Pradesh has been extended till further orders with more relaxations. The buses within the state will play with 50 per cent occupancy. Timing of the opening of shops has been increased from 9 am to 5 pm from Monday. Earlier the shops were allowed to open from 9 am to 2 pm. However, the shops except those of essential commodities will remain closed on Saturdays and Sundays.

The decision to extend the curfew was taken yesterday at a cabinet meeting chaired by Chief Minister Jai Ram Thakur. The curfew will continue from 5 pm to 5 am in the state till further orders. It was also decided that the offices will function with 50 per cent of staff from Monday. All the medical colleges, ayurvedic colleges and dental colleges will open from June 23. Pharmacy and nursing schools will open from June 28. Now there will be no requirement of RT-PCR negative tests for entering in the state.

Monsoon likely to reach Delhi by 15th June, 12 days ahead of schedule

Southwest monsoon is likely to reach Delhi by 15th of June, 12 days before its usual date of June 27. India Meteorological Department (IMD) said, conditions are favourable for an early onset of monsoon in Delhi.

It said, under favourable meteorological conditions, monsoon is likely to advance over the entire country outside south Rajasthan and Kutch region of Gujarat during the next five-six days. In 2008 also, monsoon had reached Delhi on June 15. Last year, monsoon had covered the entire country by June 29, seven days before the usual date of July 8.

Tamil Nadu govt extends lockdown in state till 21st june

Tamil Nadu government has extended the lockdown in the state till 21st of this month with more relaxations. The State Government has allowed functioning of beauty parlour, saloons and spas without air conditioning facilities with 50 per cent staff and customers. Government managed parks and play grounds will be opened from morning 6 to 9 p.m. only for walking exercise.

Opthalmologist and mechanic shops will be opened from morning 9 to 2 p.m., agricultural shops, handicrafts manufacturers are allowed to function from morning 6 to 5 p.m. TASMAC will be opened from morning ten to evening five o’clock. Mobile phones and accessories, building materials, household furniture and utensils shops will be opened from morning 9 to afternoon two. Administrative activities on admission to schools, colleges and Universities have been allowed.

Export manufacturing units are allowed to function with 50 per cent staff. Industries can provide identity cards to their workers with e-registration. IT offices will be allowed to function with 20 or ten per cent workers. Housing finance companies and Non-Banking Financial Institutions can work with 33 per cent staff. Thermal screening, social distancing, face masks and hand sanitising have been made mandatory in all the activities.

Maharashtra CM asks Sarpanchs to use local dialect, folk arts to spread COVID awareness

Maharashtra Chief Minister Uddhav Thackeray has asked village heads or Sarpanchs to make a resolve that will strictly implement COVID-appropriate behaviour and protocol to prevent the possibility of a third wave of coronavirus infections. While addressing a virtual meeting with the village heads of Aurangabad, Nagpur and Amravati region, Maharashtra Chief Minister Uddhav Thackeray said that sarpanchs must use the local dialect and folk arts to spread awareness regarding Covid related guidelines.

He also praised the village heads for their efforts to keep their respective villages Covid-free and for optimal use of social media like Whatsapp. The Chief Minister informed the village heads that vaccine doses will be distributed as per availability and the same must be used as vaccines have proved effective in lowering the risk of infection.

He said that the local teams must be formed to keep a tab on the health conditions and infrastructure requirements to minimise the need for hospitalisation. Also present in the meeting, state Rural Development Minister Hasan Mushriff reminded the village heads about the Covid-free village contests, urging them to make it a people’s movement.

Bihar govt set target of vaccinating another six crore people in next 6 months

Bihar government has set an ambitious target of vaccinating another six crore people in next six months. This was stated by Chief Minister Nitish Kumar after reviewing the status of covid vaccination in the state. He said, over one crore 18 lakh 52 thousand people have been vaccinated in the state so far. Out of these, 24 lakh 32 thousand people are from the age group of 18 to 44 years.

Mr Kumar ordered to involve all state government employees in the vaccination drive. The Chief Minister instructed health officials to run the vaccination campaign on regular basis and use different mediums to educate people about its benefits. The CM said people should be asked to get themselves vaccinated and ensure vaccination of each member of the family. The vaccinated people must motivate their neighbours for taking jabs.

Why Should MPs Be Paid For Disrupting Parliament?

 Let me say first and foremost: I am hugely dismayed, dejected and disappointed to see how Member of Parliaments (MPs) are disrupting Parliament time and again and not allowing Parliament to function smoothly. This under no circumstances can ever be justified. These MPs don’t bother that how much money of taxpayer is getting wasted when they repeatedly adjourn Parliament and even while in session don’t allow it to function smoothly by disrupting Parliament on one pretext or the other.

                                               While craving for the exclusive indulgence of my esteemed readers, let me inform them that I am not alone in feeling so. This is the overwhelming opinion of majority of citizens of India. To top it all, even the first person of India – former President late Pranab Mukherjee  had too while he was President had openly and very strongly expressed his huge seething anger over the logjam in Parliament and said that the House is not a place for dharna and disruptions which amounts to “gagging of majority” by the minority.
                                         For my esteemed readers exclusive indulgence, let me also inform them that late Pranab Mukherjee also minced no words in making it absolutely clear that, “Three Ds are essential in a democracy and these are debate, dissension and decision. But there was no fourth D. At least my teacher did not tell me that there is a fourth D which is disruption”. His observations assumes huge significance as both the Houses of Parliament saw proceedings being washed out yet again on December 9 with the Opposition demanding the Government mourn the deaths caused due to hardships after demonetisation. Nothing on earth can be more unfortunate than this that time and again Parliament is witnessing disruption and yet MPs time and again themselves approve 100% or 200% or 300% hike in their pay as they have the unfettered licence to hike their salaries whenever they want. No one else decides for them as to how much pay they should receive. It is they themselves who decide for themselves as to how much pay they should receive.
                                                 Be it noted, the Opposition leaders also observed one month of the monetisation decision by wearing black bands and staging protests in Parliament complex. Speaking on ‘Electoral reforms for a stronger democracy’ on the occasion of Defence Estates lecture, the President Dr Pranab Mukherjee said unequivocally that, “Disruption is totally unacceptable in Parliamentary system. People send representatives to speak and not to sit on dharna and not to create any trouble on the floor.” Very rightly said and there can be no denying this!
                                                Let me be direct in asking: Why MPs have the freedom to disrupt Parliament? Why are they not permanently barred from entering Parliament if they disrupt Parliament? Why MPs have the colonial power to retain houses at taxpayer’s expense even after they complete their tenure? Why MPs salary is not deducted if they disrupt Parliament? Why are MPs not fined if they disrupt Parliament? Same is the case with MLAs when they brashly disrupt State Assemblies!
                               Truth be told, why for acquiring any government job there is a proper police verification and even if one case is found registered in any police station the concerned candidate is debarred from joining any government service but for becoming an MP or MLA you can be a Phoolan Devi and murder many and still enter Parliament and term cases as “politically motivated”? Why MPs are not made to disclose all their assets and why their unaccounted assets not seized immediately? Why MPs are not made to disclose all donations they receive publicly and same is the case with political parties? Why they are exempted from RTI Act?
                     To put things in perspective, himself a veteran Parliamentarian before becoming the President, Dr Pranab Mukherjee palpably anguished by the manner in which the winter session of Parliament has been stalled due to disruptions made no bones in saying from his inner heart that, “Disruption means you are hurt, you are gagging majority. Majority never participates in this disruption. Only minority comes to the well, shouts slogans, stop the proceedings and creates a situation in which the Chair has no option but to adjourn the House. This is totally unacceptable.” Those minority who disrupt Parliament must seriously introspect on what the President has said! But they care a damn and that alone explains why they repeatedly disrupt Parliament!
                                           As it turned out, the President noted that Parliament is in session for only a few weeks in a year. Rest is all washed out in disruption. Now you can imagine how many crores and crores of rupees are wasted for no purpose by MPs and they have no regret in doing so and will also give hundred reasons to justify it. You just cannot convince them under any circumstances because they think that what they do is right and rest all others are wrong including the President!
                                        For all practical purposes, it is in national interest for Parliament to function normally so that all important Bills are passed and meaningful discussion takes place in Parliament. But what we hear in Parliament is nothing but shouting and slanging matches except on few occasions when few members speak on serious issues and they too are frequently disrupted. When will this end?
                           While maintaining that he was not targeting any single party or individuals, the President was quite forthright in saying that the responsibility of allowing Parliament to function is of everyone. He said that, “Fact remains that this (disruption) has become a practice which should not be acceptable at all. Whatever be the differences, we have the opportunity to speak our mind, to speak freely and no court can interfere in what I say on the floor of the House.” Why can’t MPs pay heed to what President Dr Pranab Mukherjee has said with a heavy heart?
                                                   To say the least, President Dr Pranab Mukherjee pointed out that even if a member is leveling an allegation against someone, no court can prosecute him because he has said so on the floor of the House. President  minced no words in making it clear to all MPs that, “This type of freedom should not be misused by causing disruption”. It is high time and now this freedom must be ended once and for all so that MPs are also held liable just like any other ordinary individual!
                                                Recalling the past days, President pointed out that, “When India’s budget was paltry and when outlay of Five Year Plan was very meager, two-thirds of time of Parliament was devoted to discussing money and finance. This was because elected representatives in Lok Sabha have singular right under which no tax can be imposed without their approval and neither can any money be withdrawn from the consolidated fund without their approval. No amount can be spent from the consolidated fund of India without the approval of Parliament. But if these issues are not debated, when you are spending Rs 16 lakh to Rs 18 lakh crore per year, if these things are not properly scrutinized on the floor of the House, not debated, not discussed, I do not see that our parliamentary system can be very effective and can proceed successfully.”
                                            What  an unbeatable irony that our former President late Dr Pranab Mukherjee  said with a very heavy heart that, “Don’t disrupt Parliament. For God’s sake, do your job.” But Opposition is just not prepared to abide by what he is appealing them to. Not just this, even the Government is no less and they too want that MPs should have unfettered licence to do what they want to do and as they like to do and under no circumstances should they be punished in any manner. Nor should they be thrown out of Parliament nor should their salary be deducted nor should they be punished in any other manner, nor should there be any educational qualifications for them nor should they be debarred even if many criminal cases are pending against them!
                      For how long? If any other person does anything slightly wrong especially those in government services they are immediately thrown out but why MPs are above all such rules and regulations? MPs must be made to pay for the disruption they cause and no salary should be given to them under any circumstances for the time they disrupt Parliament. No MP should be allowed to disrupt Parliament and they must be thrown out if they insist on disrupting Parliament and should be permanently barred from entering Parliament which is the highest institution of democracy! This will be the best tribute that we can pay to Parliament! Nothing better than this!
Sanjeev Sirohi,