Paraguay quarantines Indian vaccine pending Brazilian ruling

RIO DE JANEIRO, BRAZIL – Paraguay quarantined the 100,000 doses of Covaxin donated by India while awaiting the opinion of Mexico and Brazil’s health regulatory bodies, the latter not approving its emergency use for the moment, advised the Ministry of Health on Tuesday, March 30.

The batch delivered on Monday is part of another 100,000 doses that will arrive this week as part of the Indian government’s cooperation with Paraguay, which in principle plans to buy two million doses of the vaccine produced by Bharat Biotech.

“These vaccines will remain in quarantine (…) until we can verify the safety and efficacy,” Maria Antonieta Gamarra, director of the Health Regulator of the portfolio, announced at a press conference.

Gamarra said that they are in permanent contact with the Federal Commission for Protection against Health Risks (Cofepris) of Mexico and the National Health Regulatory Agency (Anvisa) of Brazil to certify the use of the vaccines in the population.

According to Paraguayan authorities, Cofepris approved Mexico’s purchase intention, while Anvisa notified Paraguay this Monday that Bharat Biotech did not get the certificate of good manufacturing practices.

Gamarra assured that the opinion of these two bodies and those of Chile, Colombia, and Argentina weigh when considering the entry of biologics in Latin America.

In any case, he added that the Indian manufacturer has “several possibilities” to revert the negative report, correcting the observations “which can be documentary or critical points in production.”

For his part, the director of the Expanded Program of Immunization (PAI), Héctor Castro, pointed out that Covaxin is a vaccine “which is in phase 3 development with more than 25,800 volunteers ranging in age from 18 to more than 90 years old.”

At the time of receiving the vaccines, Castro said on Monday that Covaxin, approved in India, Iran, Nepal, and recently in Mexico, “is safe, has an inactivated virus platform”, and that with the 100,000 doses, “50,000 people will be immunized at four-week intervals.” Gamarra detailed that Nicaragua is the only Latin American country that has approved its use.

So far, Paraguay had received in several shipments, a total of only 63,000 doses from various sources since mid-February, when the process of immunization of health personnel began; it is still in progress and is expected to be completed by April 7.

The first batch was Sputnik V, 4,000 vials of a total purchase of one million from Russia, followed by 20,000 Coronovac donated by Chile, another 3,000 from Sinopharm of the United Arab Emirates batch of 36,000 from AstraZeneca of the Covax platform.

Last October, the Paraguayan government ordered a total of 4.3 million doses from this equal distribution platform of the World Health Organization (WHO) to vaccinate 30% of its population of seven million.

Paraguay is experiencing a second wave of Covid-19, with a daily average of 2,000 infections in the last few days when the country is in quarantine until the end of Holy Week.

To date, the number of deaths has risen to 4,113, and the number of infections accumulated over the past year to 210,425.