Analysis: What Is Covaxin, the Indian Vaccine That Could Also Reach Brazil?

RIO DE JANEIRO, BRAZIL – In recent weeks, some of the most promising vaccines under development against Covid-19 have released their preliminary clinical trials results on efficacy and safety. Four of the 11 vaccines in Phase 3 trials on a global scale, the last step before filing for registration, have already provided satisfactory safety and efficacy data on protection against the disease.

Although the federal government has only signed a contract with AstraZeneca, recent news suggest that members of the Ministry of Health have also been talking with the other three institutions to negotiate the purchase of vaccines.

In these talks, which may define which will be the first immunizers to vaccinate the Brazilian population, a fifth vaccine has begun to emerge – and it is not the Chinese Sinovac caught up in the political quarrel between the state and federal governments.

Rather, it is the Indian Covaxin vaccine. With the spotlight on other immunizers, the Covaxin has so far almost gone unnoticed.

Covaxin, the Indian vaccine

Supported by the Indian government, Covaxin is being developed by Indian pharmaceutical company Bharat Biotech in partnership with the Indian Medical Research Council. The vaccine is expected to be launched on the market for emergency use in February 2021, months earlier than its developers had expected. The initial plan was to launch the vaccine in July next year.

“The vaccine showed a good efficacy. By early next year, February or March, something is expected to be available,” Rajni Kant, a scientist with the Indian Medical Research Council, told Reuters news agency.

According to data released by Bharat Biotech itself, Covaxin volunteers presented an immune response in phases 1 and 2 clinical trials and the vaccine also proved safe, with no record of serious adverse effects. In July, Bharat Biotech was authorized to start phase 3 clinical trials of its immunizer in India.

In November, Bharat Biotech began recruiting. The laboratory expects to reach 26,000 volunteers in India for the final phase of trials, with results expected by March or April, said the pharmaceutical company’s executive director, Sai Prasad, to Reuters.

Since the start of the pandemic, India has recorded over 9.2 million cases of Covid-19, ranking second as the country with the most infections, behind the United States. With a total of 134,699 deaths, the Asian country ranks third among the countries with the highest number of deaths in the world, behind only the United States and Brazil, according to the Johns Hopkins University tally. But it is worth noting that the Indian population is also much larger than those countries: 1.3 billion people.

Covaxin production technique

The production method chosen by Bharat Biotech to manufacture its vaccine is the same technique being used to produce the CoronaVac, Sinovac‘s vaccine in partnership with the Butantan.

The Covaxin vaccine is produced from the inactivated virus. The procedure consists in injecting the inactive virus through chemical or physical agents into the body, causing the immune system to identify the invader and produce defenses against it.

Thus, when the body comes into contact with the actual virus, the immune system will have already created the required defenses to fight the disease. According to the Butantan Institute, the strategy for working with the inactive virus has already been used for the development of several other known vaccines, such as the polio and measles virus immunizers, for instance.

Indian vaccine on its way to Brazil?

According to Prasad, Bharat Biotech has proposed a bilateral agreement between India and Brazil for the sale of Covaxin. The Ministry of Health last Tuesday, November 17th, welcomed Bharat Biotech representatives to begin talks on the potential agreement.

In the same meeting, Ministry officials heard proposals on the supply of immunizers from Pfizer and Gamaleya Institute – vaccines still with no agreement with Brazil.

In a note, the Ministry stated that the goal was to learn about “the results of ongoing trials and the conditions of purchase, logistics and storage offered by the laboratory,” while failing to provide further details on what was or was not agreed.

The portfolio also said that the purchase of vaccines should occur once studies prove the product’s complete safety and efficacy and ANVISA approves the registration. But, as mentioned, the Indian vaccine is still in phase 3 trials and has no results on efficacy to date. “The Ministry should soon present the Brazilian population immunization plan against Covid-19,” says the statement.

The Ministry of Health’s technical group in charge of preparing the vaccination strategy against Covid-19 should meet on Monday to prepare the first draft of the vaccination plan. This group is made up of officials linked to the National Health Council and the National Council of Municipal Health Secretariats.

The aim is to follow the logistic plan used in all vaccinations, provided in the PNI (National Immunization Plan). But the technical group is expected to draw up different scenarios, since it is unclear which immunizer will be adopted and in how many phases it will be administered.

Which vaccines will actually reach Brazil?

Although there are talks between India and Brazil for the purchase of the drug, Brazil has two official agreements for the purchase of vaccine doses: one with Oxford University and the other with the Covax consortium, an initiative of the World Health Organization (W.H.O.).

The federal government’s first choice, for the time being, is on the immunizer developed by Oxford University and the AstraZeneca laboratory. The government has invested R$1.9 billion to buy 100 million doses of the vaccine, in addition to equipping Fiocruz for domestic production of the drug.

The estimate is that vaccination with the Oxford vaccine will begin in March. “The vaccine will not be applied on a massive scale,” explained Nísia Trindade Lima, president of Fiocruz. “There will need to be some priority criteria, but this has not been defined yet.”

It is worth noting that recently the Oxford vaccine was criticized by the international community for omitting a dosage error when the results of preliminary efficacy were disclosed.

However, the pharmaceutical company and Oxford clarified the problem and included this half dose administration regime in the study. They also reported the change to the UK, U.S. and EU regulators.

Brazil is also part of the Covax Facility, a W.H.O. initiative for the distribution of licensed immunizers. The country expects to be provided doses to 10% of the population through this international consortium.

Brazil has invested R$2.5 billion to join the Covax Facility – which still has not defined which vaccines the consortium will have at its disposal, although specialists believe that the Moderna immunizer is among the chosen vaccines. For a vaccine to be authorized to be administered in Brazil, the immunizer must be approved and licensed by ANVISA.

Beyond the federal sphere, state governments have also signed agreements with pharmaceutical companies. This is the case of the government of São Paulo with the Sinovac vaccine, developed in partnership with the Butantan Institute.

According to the São Paulo government, there is a commitment to acquire 46 million doses of the CoronaVac and the Butantan Institute is adapting a plant to produce the vaccine in national territory. The first 120,000 doses have already reached Brazil and are being stored in São Paulo.

Furthermore, there are negotiations between private companies and the state governments of Paraná and Bahia with the Gamaleya Institute, responsible for the Russian Sputnik V vaccine. Both governments have already closed agreements with the Russians for future clinical trials in the country and for the purchase of doses. However, to date, ANVISA has not received a formal request from the Gamaleya Institute for testing or registration of the Sputnik V in Brazil.

In Brazil, União Química from São Paulo has signed an agreement to receive the Russian technology and produce the immunizer. A spokesperson for the pharmaceutical company said that it has already received part of the raw materials to produce the immunizer. According to Rogério Rosso, União Química’s international business director, the raw material is part of a pilot lot, which will be used for research and development.

Source: InfoMoney