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Gennova Biopharmaceuticals to kick off early- to mid-stage human trials of its Covid-19 vaccine candidate

Gennova CEO-Dr Sanjay Singh

India based pharmaceutical companies are also in the vaccine race. Pune-based Gennova Biopharmaceuticals is planning to kick off early- to mid-stage human trials of its Covid-19 vaccine candidate “soon”. For this purpose, it would be enrolling around 620 participants across several sites over the next few months.

Gennova CEO-Dr Sanjay Singh said, “We have started the processes. We hope to start phase 1 soon. We will present our phase 1 data to the DCGI (Drug Controller General of India), before starting the second phase, and so the timeline for the trials to be completed will depend on these factors.”

“For phase 1, we have got two sites where we will be starting enrolment soon,” he said, adding that around 120 volunteers will be registered in the first phase at two sites, KEM Hospital, Pune, and a government hospital in Kolhapur. Singh further said, “We are looking at enrolling 500 participants for phase 2 trials and this will go into many sites. I hope it will be 6-10 sites.”

The DCGI, who heads India’s apex drug regulator, last week gave Gennova the green light for phase 1/2 trials. If successful, the vaccine may be the first indigenously developed vaccine using mRNA technology that could potentially use India’s existing cold chain capacity in its distribution.

This is the same platform used by Pfizer/BioNTech and Moderna and the US National Institutes of Health (NIH) to make their vaccine. Preliminary information released on the two vaccines with respect to late-stage trials shows that they have an efficacy of around 94-95 percent.

According to the Ministry of Science and Technology, Gennova’s candidate, known as HGCO19, is “stable” at 2°C to 8°C for two months. On the other hand, the Pfizer/BioNTech vaccine requires deep freeze technology to be stored at around -75°C and can be kept in 2°C to 8°C refrigerated units for up to five days. Moderna’s candidate can survive in these refrigerated temperatures for up to a month.

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SII will apply for emergency authorization of COVID-19 vaccine as the Astrazeneca- Oxford vaccine is suitable for LMICs in terms of distribution

COVID-19 vaccine

SII Chief Executive Adar Poonawalla said that in the next two weeks, Serum Institute of India will apply for emergency authorization of COVID-19 vaccine. The Pune based drugmaker partnered with global pharmaceutical giant AstraZeneca to produce COVID-19 vaccine developed by the University of Oxford for low-and-middle-income countries. The COVID-19 vaccine, dubbed as Covishield, is currently in the Phase III clinical trial in India. In this regard, SII-CEO Adar Poonawalla has said that indications suggest that the Indian Government may purchase 300 to 400 million ‘Covidshield’ doses by July next year.

Covidshield is a highly effective vaccine against novel coronavirus. AstraZeneca and Oxford University earlier said that their drug had proved on an average 70% effective at stopping the virus after trying it on 23,000 people. But, top scientists in World Health Organization stated that more data is needed to determine if the Astrazeneca vaccine works.

The world’s largest vaccine manufacturer by volume said that India will be given first priority for the delivery of the AstraZeneca-Oxford vaccine. A collaboration between the Serum Institute of India (SII), GAVI, and the Bill & Melinda Gates Foundation is driving the manufacture and delivery of up to an additional 100 million doses of safe and effective COVID-19 vaccines for low- and middle-income countries (LMICs) like India as part of the Gavi COVAX AMC, a mechanism within the COVAX Facility.

A total of 172 economies are now engaged in discussions to potentially participate in COVAX, a global initiative aimed at working with vaccine manufacturers to provide countries worldwide equitable access to safe and effective vaccines, once they are licensed and approved. COVAX currently has the world’s largest and most diverse COVID-19 vaccine portfolio – including nine candidate vaccines, with a further nine under evaluation and conversations underway with other major producers.

This development comes after AstraZeneca and Oxford University have acknowledged a manufacturing error which has raised questions about preliminary results of their experimental Covid-19 vaccine. The error was found when a study was carried out in a low dose and full dose setups. In the low-dose group, AstraZeneca said, the vaccine appeared to be 90 percent effective. In the group that got two full doses, the vaccine appeared to be 62 percent effective. Combined, the drugmakers said that the vaccine appeared to be 70 percent effective.

But that does not cancel out the hope of the Covidshield vaccine of AstraZeneca.

Andrea Taylor, assistant director of programs at Duke Global Health Innovation Center said, “The Pfizer vaccine is committed to its initial doses going to the EU and the US. And Moderna’s supply will be tied up with the US for at least probably the first half of 2021, so in light of that, the Oxford/AstraZeneca vaccine is really good news for the rest of the world.”

The vaccine developed at England’s Oxford University planned to be distributed in India is significantly cheaper than the others and, crucially, it would be far easier to transport and distribute in developing countries than its rivals since it does not need to be stored at freezing temperatures.

The author is a student member of Amity Centre of Happiness

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Phase-III trials begin for Bharat Biotech’s COVID-19 Vaccine-Covaxin while Biological E Ltd began adaptive Phase I and II human trials

bbio tech

Bharat Biotech has declared the beginning of Phase-III trials of COVAXIN.  This trial will cover 26,000 volunteers across India and will be carried out in partnership with ICMR. It is the largest clinical trial performed for a COVID-19 vaccine in India.

This is India’s first Phase-III efficacy study for a Covid-19 vaccine. The trial volunteers will get two intramuscular injections almost 28 days apart. Participants will be randomly selected to take Covaxin or placebo. The trial would be double-blinded where the investigators, participants, and the company will not be informed of who has been assigned to which group.

In Phase I and Phase II Clinical trials, COVAXIN has been assessed in approximately 1,000 subjects, giving promising safety and immunogenicity data. The volunteers who want to participate in the Phase-III trial should be over 18 years of age. Joint Managing Director of Bharat Biotech, Suchitra Ella, told that the development and clinical evaluation of COVAXIN have garnered interest from several countries worldwide for supplies and introduction.

Russia’s sovereign wealth fund, also known as Russian Direct Investment Fund, has published the results of a survey of 12,000 respondents in 11 countries regarding Covid-19 vaccination and preferences in vaccine selection. As per the results, 73 percent of respondents were willing to be vaccinated. Among those aware of Russia’s Sputnik V vaccine, the number was higher at 4 out of every 5 respondents.

A UK research data and analytics group, YouGov conducted the survey from October 9-19. The survey was conducted before the announcement that the Sputnik V is 92 percent effective at protecting people from Covid-19, as per interim trial results. The survey found that a majority of participants in India are positive about vaccination at about 80%. Among those aware of Sputnik V, the percentage of those willing to be vaccinated is over 85 percent of those surveyed.

In a parallel development, Biological E Ltd, a Hyderabad-based firm has started an adaptive Phase I and II human trial for its COVID-19 vaccine candidate. The firm has already sought approvals from Drugs Controller General of India (DCGI) and expects to get the results back by February, next year.

It is being developed along with Baylor College of Medicine (BCM ventures) in Houston, Texas, and Dynavax Technologies Corp. According to the press release by Biological E Ltd, the trial will test two doses of the vaccine in around 360 volunteers who are aged between 18 to 65 years. It will be administered via intramuscular injection 28 days apart. Intramuscular injection is a technique used to deliver the vaccine deep into the muscles, allowing it to be absorbed into the bloodstream quickly.

The author is a student member of Amity center of Happiness

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COVID vaccine update: Johnson & Johnson to start testing in teens; Centre asks states to plan rollout

Johnson & Johnson plans to start testing its experimental COVID-19 vaccine in youths aged 12 to 18 as soon as possible, a company executive said at a meeting held by the US Centers for Disease Control and Prevention (CDC) on Friday.

“We plan to go into children as soon as we possibly can, but very carefully in terms of safety,” J&J’s Jerry Sadoff told a virtual meeting of the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices on Friday.

Depending on safety and other factors, the company plans to test in even younger children afterwards, said Sadoff, a vaccine research scientist at J&J’s Janssen unit, without giving a timeline.

The Centre today began preparations for the introduction of potential Covid-19 vaccines, asking states to create three-tier mechanism to facilitate the process. In a letter to chief secretaries, Union Health Secretary Rajesh Bhushan said Covid-19 vaccine introduction would most likely span over a year with multiple groups being included sequentially starting from healthcare workers.

He said the vaccine would initially be available in limited quantities. “It is anticipated that initially the supply of vaccine will be limited in view of huge demand, hence prioritisation of socio-demographic groups will be done for vaccination and subsequently other groups will be included,” states the Health Secretary’s letter.

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Vaccination push readied by the government of Uttar Pradesh when GOI asked states to form committees in this regard

As medical and research institutions across the country are preparing for the third phase trials of the country’s first indigenously developed COVID-19 vaccine, Covaxin, Uttar Pradesh is gearing and wrapping up a vaccination drive in the state.

This comes in a context when the GOI had asked the states to constitute committees for coordination and overseeing COVID-19 vaccination drive while ensuring that there are minimal disruptions in other routine healthcare services. This direction also stressed early tracking of social media to dispel rumours which could impact the community acceptance of coronavirus vaccine inoculation.

The direction by GOI has stated that the COVID-19 vaccine introduction will span over a year with multiple groups being included. It also added that the drive would begin from health care workers (HCW).

The Health Ministry has also sought constitution of committees at state and district levels which will review preparatory activities in terms of cold chain preparedness, operational planning, strategies for state-specific challenges in terms of geographical terrain and hard-to-reach areas in the last mile reach approach.

In this regard, the UP government has directed all the Districts and chief medical officers to recruit public and private health workers on first priority for vaccination. District health department officers have also been asked to prepare an arrangement of cold chains in all districts for storing the vaccine by December 15. The UP government also stated that in the first phase frontline health workers like doctors and paramedical staff will be vaccinated.

In a letter to states and union territories, Union Health Secretary Rajesh Bhushan has suggested the setting up of a state steering committee (SSC) chaired by the chief secretary, a state task force (STF) led by additional Chief Secretary or principal secretary (health), and a district task force (DTF).

Amit Mohan, UP additional chief secretary has stated that the state health and family welfare department has ordered the district administrations and health officers (district) to complete all the preparation for the vaccination before it gets ready for launch. In the state, the third phase trials of Covaxin will be carried out at SGPGI, Lucknow, and BRD Medical College, Gorakhpur. Keeping in context with the large area and population, the state health department has resolved to complete all the preparations by the year-end. To check the spread of the infection, the State Health  and Family Welfare Department (UP) recently launched a ‘16 day focused sample test drive’, across the state.

The author is a student member of Amity centre of Happiness.   

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Free COVID-19 Vaccine for all the citizens of India, states Union minister Sarangi amid backlash

Union Minister of state, Pratap Sarangi said that all people of the country will be given free corona-virus vaccine, in response to demand by the opposition. The parties led by INC in the opposition wing had placed a demand for free vaccine for all the citizens of India, not only in the poll-bound Bihar as was proclaimed by the BJP in its election campaign.

The announcement of free vaccine in Bihar had raised a whirlpool of controversy-storm with the opposition parties blaming the NDA government that it was using the pandemic for political gain. A guessed estimate of Rs 500 will be spent on vaccine for each person as stated by Sarangi in a campaign for the assembly by-poll bound Balasore.

Bishnu Charan Sethi, BJP deputy leader in Odisha Assembly, in a bid to bring attention to the efforts of centre towards the state said that the Centre has been supporting Odisha during the pandemic and that the GOI has granted Rs 22,000 crore for the purpose.  Odisha Food Supplies and Consumer Welfare Minister, R P Swain said that the state had signed an agreement with a vaccine manufacturer to extend the availability of Covid vaccine to all people of the state. But it was not clarified whether the state will provide the vaccine free of cost to the people.

It had been earlier declared that Indian scientists are in the process of developing several vaccines which are at different stages of clinical trials. The government of Tamil Nadu, Madhya Pradesh, Assam, and Puducherry had already announced free of cost COVID vaccine for the people of their respective states while Delhi CM-Arvind  Kejriwal had asserted that free vaccine be given to all citizens across the country.

The author is a student member of Amity Centre of Happiness.  

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Logical strategies for Covid-19 vaccine procurement and storage under process, says GOI

Various vaccine candidates have now entered the phase-3 trials against Covid-19, following which the Central government has begun making logical strategies for their acquisition, storage, and distribution. Several storage facilities have been selected by the government for cold storage as most of the vaccines have a specific temperature required to remain effective.

Subgroups under the National Expert Group on Vaccine Administration for Covid-19 have been assigned with the responsibility of supervising cold chain facilities for vaccine storage, development, and storage which is headed by the Chairman Dr. VK Paul,  and Niti Aayog.

As per a statement by the Union Health Secretary, Rajesh Bhushan, the subgroups responsible for this task have already been mapped and they have selected government and public facilities for vaccine storage and development. At present, most of them are working on certain modifications to be carried out, suitable for cold storage of the vaccine.

Harsh Vardhan, the Union Health Minister said that the government is presently focusing upon the acquisition of approximately 500 million vaccines, for a population of almost 250 million.

An interesting update on the Covid-19 vaccine is the real-time monitoring of vaccine storage and development from acquisition to distribution. In this process all steps are being closely tracked using the electronic Vaccine Intelligence Network (eVIN). This is a cloud-based system that functions on the information fed by the ground workers, monitoring real-time stocking, storage, and passage of vaccines from different routes.

On average, 27,000 storage facilities are present all over India in approximately 700 districts which are connected via eVIN for real-time tracking. These facilities have been incorporated with almost 40,000 workers on the frontline and 50,000 temperature loggers to monitor the temperature variations within the storage facility.

VK Paul said that they are ready with a“well-oiled machinery” for vaccine distribution and delivery along with a strong national immunization program which is already in transit. He further added that there are also other vaccines that require cold storage such as the polio and measles vaccine, so it will not be a problem as they have already managed to do so previously. He assured that the government has sufficient financial resources for the vaccine development program.

Former head and advisor of the pharmacology department and the Translational Health Science and Technology Institute, Dr. YK Gupta believes that India is capable of handling the logistics as they already have an enormous Universal Immunization Program running perfectly, which can be utilized for vaccine delivery system too. He added that a lot of logistical arrangements are currently being made in a well-coordinated manner that should see us through.

Although the procurement, storage, distribution, and delivery systems for the Covid-19 vaccine have been decided, a price based on them has not been fixed yet. Bhushan said that since the vaccines have not been tested yet for their safety and efficacy, it is hard to put a price on a single-dose or a double-dose vaccine whatsoever. Once they have been declared safe and effective, a fixed price can be assigned to the vaccines which will be lower than what was initially decided. Till then, there is no point in fixing a definite price on the vaccine doses.

The author is a student member of the Amity Centre of Happiness.

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US refuses to join WHO’s global effort to find coronavirus vaccine

On Tuesday, the Trump administration denied working with an international cooperative effort to develop and distribute a COVID-19 vaccine because it does not want to be constrained by multilateral groups like the World Health Organization.

The Washington Post first reported the decision to go it alone which follows the White House’s decision in early July to pull the United States out of the WHO. Trump claims the WHO needs reform and is heavily influenced by China.

There are Some nations who have put their effort to secure supplies of vaccine, but others are merging efforts to ensure success against a disease that has no geographical boundaries.

That cooperative effort of more than 150 countries who are setting up the COVID-19 Vaccines Global Access Facility, or COVAX, has been linked with the WHO. It would allow the nation to take advantage of a portfolio of potential vaccines to ensure their citizens are promptly covered by whichever ones are considered effective.

The WHO Utters, governments dealings with individual vaccine makers would be beneficial from joining COVAX, because, in case the bilateral ones being made through bilateral deals with manufacturers aren’t successful the government will have a backup vaccine.

”The United States will continue to engage our international partners to ensure we defeat this virus, but we will not be constrained by multilateral organizations influenced by the corrupt World Health Organization and China,” said White House spokesman Judd Deere.

Rep. Ami Bera, D-Calif., said the administration’s decision was short sighted and will hamper the battle to end the pandemic.

”Joining COVAX is a simple measure to guarantee U.S. access to a vaccine no matter who develops it first,” tweeted Bera, a medical doctor.

America’s risk of not getting a vaccine increases because of this go-it-alone approach.

The decision by the administration has linked with the U.S. withdrawal from the WHO, implies the U.S. is relinquishing America’s global supremacy in fighting pandemics, according to Tom Hart, North America director at The ONE Campaign, an advocacy organization co-founded by Bono of the rock band U2.

“Not only does this move put the lives of millions around the world at risk, it could completely isolate Americans from an effective vaccine against COVID-19, Hart said.

A handful of the dozens of experimental COVID-19 vaccines in the human trial have reached the last and biggest obstacle looking for the demanded evidence that they work.

On Monday, AstraZeneca announced that its vaccine candidate entered the final testing stage in the U.S. The Cambridge, England-based company said, ”The study will involve up to 30,000 adults from various racial, ethnic and geographic groups.’’

This summer, Two other vaccine candidates commenced ultimate trial in tens of thousands of people in the U.S. One was created by the National Institutes of Health and manufactured by Moderna Inc., and the other developed by Pfizer Inc. and Germany’s BioNTech.

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Officials to discuss COVID-19 vaccine protocols today

On Monday, The National Expert Group on vaccine administration decided to meet to discuss on logistic, procurement and administration of the coronavirus disease (Covid-19) vaccine, as and when it is ready. Dr VK Paul, member (health), NITI Aayog, heads the panel.

“The terms of reference of this expert committee are to streamline suitable vaccine selection, how procurement of vaccine will be done, how the vaccine would be delivered and prioritising groups to whom vaccine has to be administered,” said Rajesh Bhushan, Union health secretary, on Tuesday.

”Any other issues related to logistics of the vaccine like cold chain, inventory, how to arrange resources to procure vaccine and how to address the equity issues linked to vaccination will also be considered by The committee,” he said.

The committee will engage with all stakeholders, including state governments and vaccine manufacturers, on the issue in Wednesday’s meeting.

Among the 24 vaccine candidates currently under various stages of clinical trials, three are at advances stages of phase three trials in the US, UK and China.

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Government ensures efficient supply chain for Covid-19 vaccines

With the development of Covid 19 Vaccine entering the final phase, government is determined to leave no stone unturned ensuring availability of the vaccines even in the remotest village of India. They have started dicussions on a wide range of issues, from logistics to ethical questions, to set the stage for a smooth supply and effective use of a vaccine when it is ready.

A government official who is involved in the discussions said that there have been at least two meetings on preparing the ground for the first vaccine. There will be more talks in the next few weeks. There are complex issues.

The person aware of this matter has said that officials of several ministries as well as the concerned department have held extensive discussions. Also, he said that the Corona management team hopes that by next year the manufacture of its vaccine will be possible.

The authorities are tracking and carefully gauging the development of at least nine Covid-19 vaccines – of which the brightest hope is the candidate of Oxford AstraZeneca.

Officials of the concerned department have started discussing further plans in India, with positive results coming up about the vaccine being prepared to prevent corona infection in the world. Once the vaccine is ready, plans are being made for its storage to use.

Officials are closely watching the development of at least nine vaccines – including two Chinese – of which the brightest hope is the Oxford AstraZeneca candidate. Pune-based, Adar Poonawala-led Serum Institute has partnered with AstraZeneca to manufacture the vaccine in India. Human trials (combined phase 2/3 trials) on this vaccine are to begin in India next month.

“Internal consultations have started so that we are fully prepared and can avoid any last-minute mess. One of the major issues is distribution in remote areas like North East India and how we have to set up large scale cold storage facilities in such areas, ”the official said.

Officials are closely following the progress of two indigenous vaccines, Covaxin and ZyCov-D, developed by Bharat Biotech and Zydus Cadila, respectively. Both are in Phase 1 of the trial.

Covid-19 cases in India crossed the 50,000-mark mark in a single day for the first time on Sunday, taking the total number of infections in the country to 1,434,476.