EMA boosts mRNA vaccine capacity, refines AstraZeneca risk-benefit

Regulatory NewsRegulatory News | 23 April 2021 |  By 

The European Medicines Agency (EMA) is working to secure additional doses of the COVID-19 vaccine developed by Pfizer and BioNTech with an aim to deliver 1.8 billion doses to Europe by the end of 2023.
After touring the Pfizer plant in Puurs, Belgium, European Commissioner Ursula von der Leyen issued a joint statement with Belgium’s prime minister and BioNTech’s chief medical officer. “I am now confident that we will have sufficient doses to vaccinate 70% of the adult population in the European Union already in July,” said von der Leyen and the others.
The anticipated contract will give Europe the capacity to give booster shots if necessary, to vaccinate children and teenagers when authorization for those age groups comes through, and to “provide vaccines adapted to escape variants that no longer respond to the vaccine,” they said.
The announcement comes as EMA approved the Puurs facility for boosted manufacturing capacity, giving the nod to increased batch sizes and “associated process scale up,” according to an EMA press release. “EMA’s decision reaffirms that the Puurs facility is capable of consistently producing high-quality vaccines and enables Pfizer/BioNTech to scale up the production process at this site.”
CHMP, EMA’s human medicines committee, further recommended approving a new filling line for Moderna’s messenger RNA COVID-19 vaccine plant in Rovi, Spain. “The new line will enable an increase in finished product fill activities, to synchronize with the active substance scale-up process at the active substance manufacturing site…approved last month,” wrote EMA.
New EMA AstraZeneca analysis
On Friday, EMA also released a new analysis of the benefits and risks of receiving AstraZeneca’s COVID-19 vaccine. The analysis, discussed Friday at an end-of-day press conference, compares the risk of a dangerous but very rare clotting syndrome by age group against the risk of hospitalization, intensive care unit admission and death in the setting of high, medium or low COVID-19 infection rates.
The “visual risk contextualization” is meant to provide European member states with another tool to use as they are deciding how to use AstraZeneca’s two-dose adenovirus vector vaccine, taking into consideration the signal for an extremely rare combination of blood clots and low blood platelet counts among a small number of individuals who received the vaccine. In general, the graphs show benefit increasing with age, and with higher rates of background COVID-19 infection.
The document, meant to clarify the approach to benefit-risk analysis, resulted in considerable confusion on the press call. Two reporters separately asked for clarification, having interpreted the graphs as meaning that the risk of the vaccine outweighed benefit for certain younger age groups.   
EMA’s head of pharmacovigilance and epidemiology, Peter Arlett, responded to the first questioner by noting that the benefits of vaccination should be examined “as a composite;” in this case, he said, where infection rates are high, “the benefit continues to be positive in certain scenarios in all the age categories.”
Another questioner asked whether her characterization was correct that the risk of ICU admission and deaths would be higher with receipt of the vaccine under certain circumstances. “No, it absolutely isn’t correct. That’s not a correct statement to say about these graphs,” responded Arlett. He clarified that “in all cases, in all scenarios, the vaccination is preventing hospitalization, intensive care unit admission and death.”
CDC weighs Johnson & Johnson benefits, safety signal
The US Centers for Disease Control and Prevention’s (CDC) vaccines committee is meeting Friday afternoon to review available data for another adenovirus-based COVID-19 vaccine manufactured by Janssen, Johnson & Johnson’s vaccines arm and consider updated recommendations for use.
Seven cases of cerebral venous sinus thrombosis with thrombocytopenia, or low platelets, have been identified among recipients of the Johnson & Johnson vaccine according to slides presented at Friday’s meeting. Additional case-finding efforts by the CDC have yielded a total of 15 cases of thrombosis with thrombocytopenia, for a rate of 1.9 cases per million vaccine recipients. All of these cases were in females. No such cases have been reported to date among recipients of messenger RNA vaccines manufactured by Pfizer and Moderna, according to the CDC slides.
At press time, the committee was still in session. Meeting materials indicate that the CDC work group considers that the benefit of the one-dose vaccine with relatively uncomplicated storage and transport requirements outweighs the very rare risk. Policy options under consideration range from recommending against use of the vaccine, reaffirming recommendations for use in all age groups with a warning statement, recommending use only in older adults, or including a specific statement for women under 50 years of age, who make up most of those affected by the rare complication.


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Tags: CDC, coronavirus, EC, EMA, EU, US

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