The president of the National Medicines Authority (Infarmed) announced this Tuesday that Portugal should receive the first vaccines from Johnson & Johnson in the second quarter.
“By the time we are here, the process must be formalized with the European Medicines Agency” (EMA) of vaccine produced by Janssen, said Rui Santos Ivo in the Eventual Commission to monitor the application of measures to respond to the pandemic and the economic and social recovery process.
According to the head of Infarmed, the new drug from Janssen (pharmaceutical company of Johnson & Johnson), single-dose, now enters the final evaluation phase and, “if all goes well” with the evaluation of its safety and effectiveness, if it is approved next month, with the first scheduled dose deliveries for the second quarter this year.
This afternoon, the European agency announced, in a statement, that “it has received an application for a conditional marketing authorization for the vaccine against covid-19 developed by Janssen-Cilag International NV”.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) will now proceed with the evaluation of the vaccine, and is expected to issue a final opinion on the marketing of the vaccine on the European market in “mid-march”, provided the data provided by the pharmaceutical company is “sufficiently comprehensive and robust” with regard to the “effectiveness of the vaccine, its quality and safety”.
Should the EMA issue a favorable opinion, it will then be up to the European Commission to issue a “decision” on the marketing of the vaccine in all Member States of the European Union.
At the end of January, the medical director at Janssen told the Lusa agency that he maintained the commitment to make vaccines available in the EU in the second quarter of this year, when Portugal will receive the first vaccines. 1.25 million doses, of a batch of 4.5 million that the country will receive throughout this year.
The agreement of this pharmaceutical company with the European Commission foresees for this year 200 million doses, with an option of 200 million additional doses.
Pfizer “practically managed to catch up”
Also according to Rui Santos Ivo, the information available at this moment indicates that Pfizer “practically managed already catch up which occurred at the beginning ”in the delivery of vaccines, which allows Portugal to count, at the end of the first quarter, with around 1.3 million doses, which is“ practically the volume that was expected ”.
Regarding Moderna, the “information we have is that the 226,800 doses that were contracted will be delivered”, said the president of Infarmed, adding that “where a reduction is actually seen in AstraZeneca vaccines”, since they were expected to be about 2.7 million have been delivered, but which should not exceed 930 thousand doses in this phase.
However, this afternoon, the European Commission confirmed that Moderna will deliver fewer doses of its vaccine during the month of February, it is expected that in March the pace of distribution will recover.
EMA has so far approved three vaccines for use on European soil: Pfizer / BioNTech, Moderna and AstraZeneca.
The covid-19 pandemic caused at least 2,408,243 deaths worldwide, resulting from more than 109 million cases of infection, according to a report made by the French agency AFP.
In Portugal, 15,522 people died from 788,561 confirmed cases of infection, according to the most recent bulletin from the Directorate-General for Health.