Connect with us

COVID-19

EMA approves several vaccine manufacturing facilities, including AstraZeneca's Halix site

SHARE:

Published

on

We use your sign-up to provide content in ways you've consented to and to improve our understanding of you. You can unsubscribe at any time.

The European Medicine’s Agency (EMA) human medicines committee (CHMP) has adopted several recommendations that will increase manufacturing capacity and supply of COVID-19 vaccines in the EU.

New manufacturing site for AstraZeneca’s COVID-19 vaccine

A new manufacturing site has been approved for the production of AstraZeneca’s COVID-19 vaccine active substance. The Halix site is located in Leiden, the Netherlands, and will bring the total number of manufacturing sites licensed for the production of the active substance of the vaccine to four.

Advertisement

AstraZeneca finally submitted its application for EMA approval for the site two days ago, it is unclear why it has taken so long to apply for approval.

When the advanced purchase agreement was agreed in August last year AZ CEO Pascal Soriot said: “With production in our European supply chain soon to be started, we hope to make the vaccine available widely and rapidly, with the first doses to be delivered by the end of 2020. I would like to thank the entire European Commission, and especially the Commissioner for Health and Food Safety, Stella Kyriakides, for their swift response in ensuring Europeans may soon be protected with a vaccine against this deadly virus, enabling our global society and economy to rebuild.”

More flexible storage conditions for BioNTech/Pfizer’s COVID-19 vaccine

Advertisement

A new site has also been approved for the production of Comirnaty, the COVID-19 vaccine developed by BioNTech and Pfizer. The facility, which is in the German city of Marburg, will produce both active substance and the finished product.

In addition to the new manufacturing facility for this vaccine, EMA is also allowing the company to transport and store the vials of the vaccine at temperatures between -25 to -15˚C (i.e. the temperature of standard pharmaceutical freezers) for a one-off period of two weeks. This is expected to facilitate the rapid roll-out and distribution of the vaccine in the EU by reducing the need for ultra-low temperature cold  (-90 to -60˚C) storage in special freezers throughout the supply chain. 

Scale-up processes for Moderna’s COVID-19 vaccine

In addition to the approval for a new manufacturing site for the production of active substance and finished product intermediates last week, Moderna will add new manufacturing lines at the Lonza facility, located in Visp, Switzerland, together with other changes to the manufacturing processes that are intended to scale-up production capacity and increase supply of the vaccine for the EU market.

COVID-19

‘We must remain vigilant’ Charles Michel

Published

on

The message from the European Council summit is that Europe must remain vigilant. Vaccination campaigns across Europe have brought progress in the fight against COVID-19, but there is a recognition that there is still a problem with vaccine hesitancy, in particular, in Romania and Bulgaria where the vaccination rates have been low. 

Charles Michel said that disinformation had to be tackled, particularly on social media platforms. 

There is ongoing work to accelerate recognition of certificates, with one important development being the recent decision of the United States to lift restrictions for vaccinated EU citizens as of 8 November, 2021.

Advertisement

In its conclusions, the European Council also called on the experiences of the COVID-19 crisis to strengthen the EU’s preparedness for future health emergencies and the conclusions of negotiations on the new Health Emergency Preparedness and Response Authority (HERA).

In the context of the upcoming G20 meeting and in view of the special session of the World Health Assembly in November, the European Council underlines its support for a strong, central role for the World Health Organization in future global health governance and for the objective of agreeing an international treaty on pandemics.

Advertisement
Continue Reading

COVID-19

EU and US propose target of 70% of world vaccinated by next year

Published

on

Today (18 October) the European Commission President Ursula von der Leyen announced that together with the Biden administration will propose a target of 70% vaccination for the world. 

Von der Leyen said the EU will do its part, on top of its expertise the EU will donate at least  500 million doses of vaccines to the most vulnerable countries. She said that other countries had to set up and that she would work with Prime Minister Draghi and President Biden to rally G20 leaders to commit to this target. 

One billion vaccines exported from the EU

Advertisement

Von der Leyen said the EU had reached an important milestone in exporting more than 1 billion COVID-19 vaccines to the rest of the world: “Vaccines from the European Union have been shipped to more than 150 countries, just to name a few to Japan, to Turkey to the UK to New Zealand, to South Africa to Brazil.”

“We delivered around 87 million doses to the low- and middle-income countries through COVAX. So we made good on our promise, we have always shared our vaccine nation production capacity fairly with the rest of the world. We've said that at least every second dose is produced in the European Union will go abroad.”

Advertisement

Von der Leyen added that this hadn’t stopped the EU from reaching its target of more than 75% of the adult population fully vaccinated. She pointed to the fact that the EU managed to do this even when vaccines were scarce.

Continue Reading

COVID-19

EU vaccinates 70% of its adult population

Published

on

Today (31 August) the EU has reached a target of 70% of the adult population fully vaccinated. More than 256 million adults in the EU have now received a full vaccine course. 

The Commission already announced that it had met its target to deliver enough vaccines to vaccinate this proportion of the population at the end of July; today’s announcement confirms that these vaccines have been administered. European Commission President Ursula von der Leyen said: “The full vaccination of 70% of adults in the EU already in August is a great achievement. The EU's strategy of moving forward together is paying off and is putting Europe at the vanguard of the global fight against COVID-19.”

Given the prevalence of the more virulent Delta variant, von der Leyen is urging EU countries and its partners to continue vaccinating at a pace. 

Advertisement

Health Commissioner Stella Kyriakides said: “I am very pleased that as of today we have reached our goal to vaccinate 70% of EU adults before the end of the summer. This is a collective achievement of the EU and its member states that shows what is possible when we work together with solidarity and in co-ordination. Our efforts to further increase vaccinations across the EU will continue unabated. We will continue to support in particular those states that are continuing to face challenges.”

The picture across the EU varies enormously; the good news hides significant differences between EU members, with Romania (26%) and Bulgaria (17%) having very low rates of vaccination. Ireland, which has a very high rate of vaccination, has been able to purchase vaccines from Romania, despite its low rate of vaccination. 

Council removes 5 countries and one entity/territorial authority travel restrictions list 

Advertisement

The Council has updated the list of countries, special administrative regions and other entities and territorial authorities for which travel restrictions should be lifted. In particular, Israel, Kosovo, Lebanon, Montenegro, the Republic of North Macedonia and the United States of America were removed from the list.

Non-essential travel to the EU from countries or entities is subject to temporary travel restriction. Member states can lift the temporary restriction on non-essential travel to the EU for fully vaccinated travellers.

Continue Reading
Advertisement
Advertisement
Advertisement

Trending