Tag: Covaxin

why hasn’t the world health organization(WHO) authorized Covaxin yet?

Traveling the world is valuable and who doesn’t want such worthwhile experience. Even In this trying times, everyone has an urge to travel the globe to experience the beauty of the world and have incredible experiences to add up in their brain’s memory bank.

But are you the one who is vaccinated by covaxin but can’t be treated as vaccinated and be permitted to travel across international borders?

Well, here are the reasons why covaxin is not approved by world health organization yet. 

First of all, we need to understand the process of getting a vaccine approved By WHO. It consists of four parts, Namely,

1. acceptance of the manufacturer’s expression of interest, 

2.A pre submission meeting between WHO and the manufacturer, 

3. Acceptance of the dossier for review by WHO, 

4.Decision on status of assessment and the final decision on approval.

Now If we talk about  the approval of covaxine which was manufactured by Bharat Biotech. The first step itself is not completed yet. That is the acceptance of the manufacturer’s expression of interests is not accepted by the WHO and more information is needed as reported by Who in order to clear the first stage. Bharat Biotech, located in Hyderabad, submitted 90 percent of the documents required for the WHO’s Emergency Use Listing in April month. The rest of the paperwork would be presented this month, according to the statement provided by the manufacturing company.

The second step which consists of a pre submission meeting between WHO and the bharat biotech will also be held in this month Meanwhile, the WHO authorized the Pune-based Serum Institute of India (SII), which manufactures Astrazeneca’s Covishield vaccine, on February 15 after passing the same four phases. The approval procedure is classified, and it is unclear what papers are needed at this time to approve covaxine. Therefore, the Indian people who got fully vaccinated by covaxine are sceptical of it’s authorization by WHO because recently, US food and drug administration also rejected Bharat Biotech’s proposal for an emergency use authorization (EUA) of Covaxin, delaying the company’s vaccine launch in that country. 

The government of india’s take on US FDA disapproval is that it respects the FDA’s decision not to grant Covaxin an EUL, but claims it will have no influence on India’s immunisation programme. Union minister of information and broadcasting prakash javedekar said in the press briefing that “The World Health Organization (WHO) has not made a judgement on whether or not persons who have been vaccinated with Covaxin should be prohibited from travelling. Covaxin is a vaccination that has shown to be one of the most successful to date.”

So, when can we expect the authorization of covaxin by world health organization is a question we all needs answer for. On June 9 bharat biotech said that the company will reveal all of Covaxin’s phase 3 trial results in July 2021, after which it will commence the phase 4 trial while concurrently applying for a complete license in India. The submission of trial results are important because it is a prerequisite for Obtaining the WHO Emergency Use Listing.

A good news for the people who got inoculated by covaxine is that so far, few countries like Iran, Philippines, Mauritius, Mexico, Nepal, Guyana, Paraguay and Zimbabwe have approved the Covaxin. But, The European Union and the United States are unwilling to let Indians who have been vaccinated with Covaxin to enter their countries since WHO authorisation is still pending.

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.

91 Nations vulnerable to new strain due to Indian vaccine export ban

91 Nations are vulnerable to the B1.617.2 strain after India has stopped export of vaccines claimed WHO: After being hit by the deadly and life taking second wave, New Delhi has banned all exports and started redirecting supplies for domestic use. India’s decision to ban exports and redirect supplies for domestic use has made a severe impact on those 91 Nations who were totally dependent on products of Serum Institute of India (SII), Covishield or AstraZeneca and the upcoming Novavax.

Without sufficient stocks these counties which are majorly African will remain Susceptible to the deadly B1.617.2 variant which was primarily found in India, said WHO . As per a chief scientist of World Health Organization, “91 countries are impacted by the shortage of supplies, particularly since the AstraZeneca parent company has not been able to compensate for the doses which have not come from Serum,” . The scientist stated that these nations are very vulnerable to new and more Transmissible strains including the B1.617.2 variant also.

The scientist added, “not just B.1.617.2, but other variants will emerge in other countries and spread around the world…We know that these variants spread very quickly. Even before they can be recognised, they are already spreading around the world. The same thing happened with the 117 [variant], now dominant“. As per an agreement signed between AstraZeneca and Serum Institute of India(SII) , SII was expected to supply a billion doses for low and middle income countries, with a commitment to provide 400 million doses by 2020 i.e. last year. All of this was to be delivered by Gavi, an international vaccine alliance.

The scientist also said that “most African countries, unfortunately, have vaccinated less than 0.5 per cent of their populations and haven’t even vaccinated all their healthcare workers,“.She also added that “if we continue having this inequitable distribution of available vaccines, we will see some countries going back to some degree of normalcy in their life, while other countries are hit very hard and continue to be hit hard by subsequent waves,“.

But after being hit heavily by the second wave, India stopped exports of it’s vaccines and redirected those for domestic use for vaccinating the natives. In this process, the nations which were dependent on Gavi and on Indian vaccines were left amid. As per some data, rich nations like US, UK, Israel, Canada and the European Union already ordered millions of vaccines from multiple vendors even before the vaccines were approved.

Now when there are no more options for the other countries, WHO has said that it hopes India will continue it’s exports again maybe somewhere at last of this year so that the other nations could also be vaccinated. The institution is “really going out with a plea to all countries to share their doses so that vulnerable groups can be protected before we start expanding to other groups such as children“. By the end of May, India has vaccinated about 3.5% of it’s total population. Indian government has also estimated that by the end of 2021 it will vaccinate every Indian.

Covid-19 vaccine can be expected by end of 2020:Serum Institute of India.

Chief Executive Officer of the Pune-based Serum Institute Of India (SII) Adar Poonawalla on Monday said the company is expecting the vaccine for COVID-19 to be ready by the year-end.

The Institute has partnered with British-Swedish drugmaker AstraZeneca to manufacture and supply the vaccine being developed by the University of Oxford under which the SII will supply over a billion doses of vaccine in India, and to other developing and under-developed countries.

However, the approval for the vaccine from the Drug Controller General of India is still awaited.

The institute is expecting to get approval in next six months.The Oxford COVID-19 vaccine trial is currently in its Phase 3 or human trial stage, and will be administered to around 8,000 people in the U.K.

chief executive Poonawalla said while referring to another vaccine candidate from India ie Covaxin of Bharat Biotech, that the company is in no hurry to produce vaccine without proper actions and tests for safety and efficacy.Once they are confident about vaccine, they would launch the vaccine but that would be still 6 months away.

However Bharat Biotech is also confident about its candidate vaccine named Covaxin and has started phase-1 human trials enrolling about 375 patients for test. It is very unlikely that Corona vaccine to be out for masses before or on 15 August, despite the letter of ICMR since human trials may take up to 6-8 months to complete even after conducting only important tests and checks.

It is very positive for the country that we are seeing candidates for vaccine which are in human trials.The vaccine developed in country will be great opportunity for Indian institutes to once again lead the world in pandemic situation.

Covid-19 vaccine updates:Bharat Biotech’s Covaxin to start phase-1 human trials,Sinovac Biotech of China in phase-3 human trials.

New covid-19 vaccine Covaxin has improved hopes of Indians after the successful trials on monkey. It is now all set to start phase-1 human trials approved by ICMR. For the Human trials of India’s indigenous Covid19 vaccine COVAXIN, 12 hospitals are selected. They will enrol participants this month, samples of Bharat Biotech’s COVAXIN are still undergoing quality and safety tests at a govt lab. Theses tests started last Friday and are expected to be finished by the end of next week. Three of the selected hospitals – Delhi’s AIIMS, Kancheepuram’s SRM Hospital and Research Centre and Vishakhapatnam’s King George Hospital are still awaiting ethics committee approvals to begin enrollment of participants for the study.

Besides Sinovac, the vaccines developed by AstraZeneca-university of Oxford and Sinopharm are the only other candidates to start third stage trial.

US-based Moderna is planning to start its late-stage trial for potential vaccine candidates in July.

Coronavirus COVID-19 vaccine India

India is making significant progress in producing the probable Coronavirus COVID19 vaccine. Many institutions in India are engaged in Research and Development for Corona vaccines in the country. Accordin to information provided by Pune based ICMR institution, National Institute of Virology and Hyderabad based CSIR institution Center for Cellular and Molecular Biology, six Indian companies are working on probable vaccine candidate for Coronavirus.

COVID19 vaccine can be developed by 2021, says WHO scientist! The chief scientist at the World Health Organization (WHO) Soumya Swaminathan has said that at least one COVID19 vaccine will be ready by 2021. Swaminathan said that we can be hopeful of seeing one “safe and efficacious” COVID-19 vaccine by the next year. Swaminathan has revealed that WHO has been discussing methods for “fair distribution of the vaccine” with its member countries.