“We are still not where we want to be,” said European Commission President Ursula von der Leyen in February. “We were late to authorize. We were too optimistic when it came to massive production and, perhaps, too confident that what we ordered would actually be delivered on time.”(Photo by EURACTIV)
The European Union, which has had a sluggish COVID-19 vaccination rollout, approved the Johnson & Johnson one-dose vaccine yesterday (March 11).
The European Union (EU) granted a conditional marketing authorization to the vaccine after the European Medicines Agency (EMA) recommended it.
The EU has been criticized for being slow in approving vaccines. The United States Food and Drug Administration, for example, approved the Johnson& Johnson vaccine on February 27. The first vaccines in Europe, however, will not arrive until mid-April underscoring another EU challenge – one of adequate supply, which has caused the 27-member organization to engage in spats with the United Kingdom and Oxford/AstraZeneca over delivery problems and turn a blind eye to Italy blocking the export of AstraZeneca vaccines to Australia.
“In a crisis, you need other management methods. Israel and the United Kingdom have organized the vaccine rollout like a military operation. The EU is doing it bureaucratically, which is why it’s slow,” said Oliver Bate, CEO of Allianz, on Bloomberg (March 10).
The European Union had administered 43 million doses by March 9, while the United States had administered 93 million doses, according to Our World in Data, a website run by the University of Oxford. The EU reports that it has 446 million people and is the world’s third largest population after China and India.
Europe is seeing an increase in new infections as new variants spread. Last week, there were 1 million new COVID-19 cases, an increase of 9 percent from the previous week, according to DW (March 11).
In an attempt to sharpen Europe’s attack of the new coronavirus, the European Commission launched a “bio-defense preparedness plan against COVID-19 variants called "HERA (European Health Emergency Preparedness and Response Authority) Incubator” on February 17.
In this plan, researchers, biotech companies, manufacturers and public authorities will work together to speed up regulatory approval of adapted vaccines, ramp up production of COVID-19 vaccines, and detect, analyze and assess variants, according to the European Commission.
Based on the annual influenza vaccine model, the EU will provide accelerated approval for adapted COVID-19 vaccines by adapting the regulatory framework such as accepting a smaller set of additional data submitted to the European Medicines Agency on a rolling basis, which means looking at data as it is released by companies rather than in one presentation.
Also, a new category of emergency use authorization will be considered with shared liability among the member states.
Emergency use authorization (EUA) was used for the COVID-19 vaccines in the U.S. and the U.K., which led to them being approved faster than if they were being considered for conditional marketing authorization.
“For an EUA to be issued for a vaccine, for which there is adequate manufacturing information to ensure quality and consistency, FDA must determine that the known and potential benefits outweigh the known and potential risks of the vaccine,” according to the U.S. Food and Drug Administration. “An EUA request for a COVID-19 vaccine can be submitted to FDA based on a final analysis of a Phase 3 clinical efficacy trial or an interim analysis of such trial, i.e., an analysis performed before the planned end of the trial once the data have met the pre-specified success criteria for the study’s primary efficacy endpoint.”
Ramping up production of COVID-19 vaccines will include working closely with manufacturers to help monitor supply chains and address production bottlenecks, supporting the manufacturing of additional vaccines addressing new variants and ensuring the EU’s manufacturing capacity.
The Johnson & Johnson vaccine became the fourth COVID-19 vaccine to be approved in the European Union, while, on the same day, eight countries suspended use of the AstraZeneca vaccine following the death of an Austrian nurse, 49, who suffered blood clotting 10 days after receiving her first dose, according to Expresso (March 11).
With the exception of Italy and Norway, the countries had received vaccines from a specific batch, ABV2856. They were Austria, Estonia, Latvia, Lithuania, Luxembourg and Denmark.
Portugal did not receive AstraZeneca vaccine doses from this batch.
The Danish national health agency recognized that, at this point, it cannot yet be concluded that there is a link between the AstraZeneca vaccine and the formation of blood clots, but countries that are suspending the use of the vaccine asked the Risk Assessment Committee of the European Medicines Agency to initiate an investigation.
After a preliminary assessment, the European Medicines Agency said that the batch of vaccines used in Austria had no problem and cannot have led to the death of the nurse.
A 35-year-old nurse from the same Austrian hospital suffered a pulmonary embolism after being inoculated. She is being hospitalized, and her condition is stable and improving.
The Johnson & Johnson vaccine was developed by Janssen Pharmaceuticals, which is owned by J&J and based in Belgium. The EU already has secured a total of 400 million doses of the vaccine, which had been under EMA review since December 2020, according to DW (March 11). It is scheduled to receive 55 million doses by the end of June, but the drug company already has said that it may not be able to deliver in that timeframe, according to SIC Noticias (March 11).
Portugal is scheduled to receive 1.25 million J&J doses in mid-April, part of a lot of 4.5 million throughout the year, according to Publico (March 11). Portugal has a population of 10.3 million. A total of 2.89% (297,422) of its population had been totally vaccinated as of March 10, according to Our World in Data. It had received 1,055,085 doses of other COVID-19 vaccines, and 757,663 first doses had been given (7.39%) to people.
The single-shot vaccine was tested in late-stage clinical trials in 44,000 participants in the United States, South Africa and Latin America. It showed an 85 percent efficacy rate against severe illness and 66 percent general efficacy against the disease, which is lower than the EU-approved mRNA vaccines, Pfizer (95 percent) and Moderna (94.5 percent), according to SIC Noticias (March 11).
The viral vector vaccine is compatible with the “standard storage and distribution processes”. J&J estimates that the vaccine will remain stable for two years at a temperature of -20 degrees Celsius and, at most, for three months at a refrigeration temperature between 2 to 8 degrees Celsius.
Three other vaccines are under rolling review by the European Medicines Agency. They are CureVac, Novovax and Sputnik V.