RIO DE JANEIRO, BRAZIL – The Oswaldo Cruz Foundation (Fiocruz) will fail to meet the deadline to deliver 100 million doses of AstraZeneca’s vaccine against Covid-19 to the National Immunization Program (PNI) by the end of this month, but maintains its commitment to close the year with 200 million doses delivered and another 180 million doses in 2022, said Mauricio Zuma, director of Fiocruz’s Biomanguinhos vaccine production unit.
Zuma said that the 100 million dose mark should be reached by the end of August, a month later than initially planned. The delay is a consequence of the late delivery of the vaccine’s active pharmaceutical ingredient (API), required for Fiocruz to bottle the immunizer in its facilities, he added.
“AstraZeneca’s expectation to anticipate API batches was not fulfilled, due to the high demand for the product. The contract is being fulfilled, but the pace established in the agreement will not allow us to complete it in July, possibly in late August,” he said.
“We thought that the greatest challenge would be to step up our processing capacity at Biomanguinhos, but the opposite occurred. Right now AstraZeneca is again trying to accelerate API supply starting in August.”
An agreement was recently announced between Fiocruz and AstraZeneca to enable the availability of enough API to produce 70 million doses.
The start of vaccine dose deliveries made with API produced in Brazil by Fiocruz is also expected to be delayed, Zuma added.
Fiocruz had initially planned to make the first deliveries of the fully Brazilian-assembled vaccine in October, but was hoping for an earlier date. However, the Biomanguinhos director now estimates that the delivery of these vaccines made with locally produced API will only occur in November.
Moreover, the technology transfer agreement with AstraZeneca took months to be finalized after intense negotiations.
“It is scheduled for October or November. It is difficult to say accurately. The batches will need to undergo long trials abroad, and also await ANVISA (Brazilian Health Regulatory Agency) approvals. We will only be able to narrow down our projections further ahead,” he said.
“Production of pre-validation batches should start later this month. There are many procedures that need to be implemented and we are within our expectations,” he assured.
Despite the slower pace of API delivery, the Biomanguinhos director maintains Fiocruz’s goal of delivering 200 million doses of AstraZeneca’s vaccine this year for the vaccination campaign against Covid-19, a disease that has killed over 533,000 people in Brazil, the second highest total in the world behind only the United States, although not the worst in fatalities per million inhabitants.
Zuma also assured that vaccine deliveries for next year are also in the planning stage. Experts have stated that vaccination against Covid-19 should occur annually, as is currently the case with the influenza immunization campaign.
In addition to AstraZeneca’s vaccine, the vaccination campaign against Covid-19 has been using the Chinese Sinovac’s CoronaVac, bottled in Brazil by the Butantan Institute, Pfizer/BioNTech and Janssen’s (Johnson & Johnson subsidiary) immunizers; the latter is a single-dose vaccine, unlike the others.
According to Ministry of Health data, approximately 53% of the population eligible for vaccination has been administered one dose of a Covid-19 vaccine, and around 19% have been administered both doses or a single Janssen dose.
Delta variant
In the interview, Zuma also said that tests showed that AstraZeneca’s vaccine was effective against the Delta variant of the coronavirus that is thought to be highly infectious. There are reported cases of the variant in Brazil, in patients in Rio de Janeiro and São Paulo.
“Our vaccine was tested and proved to be effective for this variant. But it is important that vaccination covers as much of the population as possible, and that the second dose may also be administered to the largest possible number of people,” the Biomanguinhos director said.
He also cautioned against two trends that are starting to occur in Brazil’s vaccination campaign: mixing vaccines and advancing the interval between administering the first and second doses. Zuma said that currently available data are insufficient to ensure the efficacy of such strategies.
The city of Rio de Janeiro has allowed pregnant women administered the first dose of AstraZeneca’s vaccine and people who had severe reactions to the vaccine to be given the second dose of Pifzer’s vaccine.
In the case of pregnant women, the administration of AstraZeneca’s immunizer was suspended after a rare adverse event was detected, in which a pregnant woman died after being vaccinated in Rio.
The reduction of the administration interval between doses of AstraZeneca’s vaccine was adopted in the Federal District.
“Our vaccine has been tested with 4, 8 and 12-week intervals. The trials showed that, in these intervals, the immunogenicity rate (induction of antibodies) was higher as the interval increased,” Zuma said. “That is, the 12-week interval showed the greatest increase in the immunity rate,” he explained.