Moderna, Pfizer offer shots to fight both original virus and omicron variant

18/08/2022

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U.S.-based drugmaker Moderna and Zodiac, its partner in Brazil, started March contacts with health regulator Anvisa with the intention of making a new vaccine available in the country at the beginning of 2023. Pfizer is also working to bring to the Brazilian market its shots with updated formula and expects to file a request for authorization with Anvisa this month.

The two laboratories have developed for the global market the so-called bivalent vaccine, designed to attack the omicron variant, which has become dominant in several countries including Brazil, and also to tackle the original strain of the coronavirus. So far, all vaccines used in the world are based only on the original strain. The bivalent shot, however, promises to be more effective.

This week, the United Kingdom became the first country to approve Moderna’s bivalent vaccine for use as a booster dose as autumn approaches in the Northern Hemisphere. The company’s new shot is being reviewed by health authorities in the United States, Canada, Australia, and in European and Latin American countries.

Moderna and Pfizer work with messenger RNA technology. Unlike the technology that inoculates the attenuated or inactivated virus into the body, they “teach” the body to synthesize a protein that stimulates the immune system to respond to the virus. This technology also allows vaccines to be updated more quickly.

Pfizer’s conventional Covid vaccine has already been used in Brazil since last year, as have those from AstraZeneca, Janssen, and Sinovac/Butantan. Pfizer’s bivalent vaccine would therefore mark the second stage in the company’s activities in Brazil to fight Covid-19.

In Moderna’s case, once the company has Anvisa’s approval to commercialize its Spikevax Bivalent vaccine, it will be its debut in the Brazilian market.

To operate in Latin American countries, Moderna signed in February a partnership with the Uruguay-based pharmaceutical group Adium. By the agreement, Adium became Moderna’s operational arm in the region, responsible for the registration request with the health authorities, for the logistics, for the information work to physicians, and for the dialogue with the health ministries. In Brazil, the operation is run by Adium’s subsidiary, Zodiac — which has been operating in the country for 31 years.

Alexandre Seraphim — Foto: Silvia Zamboni/Valor

“We are moving fast. It is a very complex process that involves state-of-the-art technology. Anvisa is one of the best regulatory agencies in the world and, therefore, a very demanding one,” Alexandre Seraphim, general manager of Zodiac in Brazil, told Valor.

“We have talked to Anvisa, received material from Moderna, and are preparing the documentation [of the new vaccine] to submit to Anvisa in the coming months,” he said. Mr. Seraphim says he is considering a scenario in which Moderna’s new vaccine will be available in Brazil by the beginning of 2023. “After the approval, the availability is fast.”

The executive said that the company has also already started talking with officials of the National Immunization Program so that Moderna’s vaccine is included in the federal program.

The vaccine Moderna plans to bring to Brazil will be aimed at those over 18 years old. Studies about the bivalent vaccine for children are still being carried out.

Moderna’s vaccines will come ready to use. Moderna has seven plants and more than 1 billion people have already been inoculated with the company’s traditional Covid vaccine in 70 countries. A vaccine that includes subvariants is on the plans for both companies.

Pfizer in Brazil said that it is considering submitting test data for its bivalent vaccine to Anvisa in the coming days. “We expect to file with Anvisa this month the adapted bivalent ComiRNAty vaccine BA.1 for regulatory evaluation,” the company said in a statement.

As for the arrival in Brazil of Pfizer’s bivalent vaccine, the company says this “estimate will depend on regulatory analyses, as well as definition with the Ministry of Health.” It added that “Pfizer’s vaccine supply contract in Brazil includes delivery of potential adapted vaccines and or for different age groups.”

Zodiac’s chief medical officer, the immunologist Glaucia Vespa, recalled what seems to be the dominant perception among health experts: despite a reprieve from the pandemic, the coronavirus will continue to circulate. “We are in a transition phase. We have the pandemic period, and we may have the seasonal period [of Covid-19]. Now we are living through that transition period,” she said. “And even though there may be discussions [about the evolution of the pandemic], Sars-Cov-2 is clearly here to stay.”

In Brazil, according to the Ministry of Health, 178.7 million people took the first dose and 159.9 million took the second one. The booster dose was administered to 104.7 million. The second booster dose, however, has reached a much smaller audience so far: 19 million. And the additional dose, only 4.8 million.

Brazil will continue vaccinating its population throughout 2023 – as will most countries. And manufacturers of the new bivalent vaccines see themselves in a more competitive condition to meet this demand next year.

Thiago Barbosa, head of vaccines at Zodiac, says that one vision for 2023 is that there will be a global positioning for a boost of bivalent vaccines. “I see a big challenge next year regarding vaccine availability for the whole globe, thinking of two companies that would be with ready-made vaccines that include the omicron issue,” he said. He added that the company has been working to meet this future demand from Brazil and the region.

“Brazil is the second-largest market in the world for vaccines, including Covid vaccines, by revenue. Brazil occupied the fourth position in the global scenario before the pandemic in the public and private-sector market and, with the pandemic, the country went up to the second position,” he said. “It is an extremely strategic country for any organization that wants to develop a vaccination platform.”

*By Marcos de Moura e Souza — São Paulo

Source: Valor International

https://valorinternational.globo.com/