Milestones :: Perspectives :: Research

 

U.S.: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

 

White House [U.S.]
Briefing Room
Press Briefing by White House COVID-19 Response Team and Public Health Officials
March 26, 2021 • Press Briefings

FACT SHEET: Biden Administration Announces Historic $10 Billion Investment to Expand Access to COVID-19 Vaccines and Build Vaccine Confidence in Hardest-Hit and Highest-Risk Communities
March 25, 2021 • Statements and Releases

Press Briefing by White House COVID-19 Response Team and Public Health Officials
March 24, 2021 • Press Briefings

Press Briefing by White House COVID-19 Response Team and Public Health Officials
March 22, 2021 • Press Briefings

COVID Data Tracker March 27, 2021

 

 

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NIAID Statement on AstraZeneca Vaccine
March 22, 2021 — Late Monday, the Data and Safety Monitoring Board (DSMB) notified NIAID, BARDA, and AstraZeneca that it was concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial. The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data. We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible.
Authorization and guidelines for use of the vaccine in the United States will be determined by the Food and Drug Administration and Centers for Disease Control and Prevention after thorough review of the data by independent advisory committees…

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Europe: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

EMA
EMA: Increase in vaccine manufacturing capacity and supply for COVID-19 vaccines from AstraZeneca, BioNTech/Pfizer and Moderna
News  26/03/2021
EMA’s human medicines committee (CHMP) has adopted several important 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.

New manufacturing site and more flexible storage conditions for BioNTech/Pfizer’s COVID-19 vaccine
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. There are currently three active substance manufacturing sites supplying the EU included in the marketing authorisation.
In addition to the new manufacturing facility for this vaccine, the CHMP has also given a positive opinion to allow transportation and storage of vials of this 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 an alternative to the long-term storage of the vials at a temperature between -90 to -60˚C in special freezers. It 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 storage conditions throughout the supply chain.

New manufacturing site and scaled-up processes for Moderna’s COVID-19 vaccine
Already last week, the CHMP recommended approving the addition of a new manufacturing site for the production of active substance and finished product intermediates for Moderna’s COVID-19 vaccine. The addition of the new manufacturing lines at the Lonza facility, located in Visp, Switzerland, together with other changes to the manufacturing processes that were greenlighted by the Committee are intended to scale-up production capacity and increase supply of the vaccine for the EU market.

The changes described will be included in the publicly available information on these vaccines on EMA’s website…

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European Commission

Remarks by Executive Vice-President Dombrovskis at the press conference on the export transparency and authorisation mechanism and an accelerated approval of adapted vaccines against COVID-19 variants
Speech 24 March 2021
… Today, the Commission has adopted an implementing regulation to adapt our export authorisation mechanism for vaccines, with the aim of preserving the security of our supply chains.
As you know, the mechanism was introduced on 30 January 2021, and was recently extended until 30 June, with wide support of EU Member States.
The system has introduced much-needed transparency in relation to vaccine deliveries in the EU.
We have used this mechanism in a balanced way.
We have authorised exports on the basis that they did not threaten the commitments undertaken by pharmaceutical companies under their Advance Purchase Agreements. Of 381 requests, 380 have been approved.
Only one request for export authorisation was not granted, since it would have compromised the commitments of AstraZeneca. I remind you that AstraZeneca has only delivered a small portion of its agreed contractual commitments.
Europe has taken every step to act fairly and responsibly, mindful of our global leadership role, since the start of the pandemic. The EU remains the biggest global exporter of vaccines. We are the largest contributor to low and middle income countries in the so-called COVAX facility.
You only have to look at the figures: 43 million vaccines to 33 countries since the end of January.
And that only covers the countries which are subject to export authorisation systems. There are many more vaccines going to other countries. No one else has done as much.
We see, however, that continuing shortfalls in production are not distributed fairly across different contracting countries.
The EU is the only OECD producer that continues to export vaccines to countries that have production capacities of their own. But when these countries do not export to the EU, there is no reciprocity.
The EU still faces a very serious epidemiological situation and continues to export significantly to countries whose epidemiological situation is less serious than ours, or whose vaccination roll-out is more advanced than ours.
To address these imbalances, President von der Leyen last Wednesday called for reciprocity and proportionality to be introduced in our transparency and authorisation regime. Accordingly, we have today adopted two adjustments to the existing mechanism.
These are necessary to achieve our objective of ensuring timely access to COVID-19 vaccines for EU citizens.
Going forward, Member States and the Commission should now consider two additional elements when assessing the impact of planned exports.
First, reciprocity.
If the country of destination, which has a large production capacity, restricts its own exports of vaccines or substances – either by law or other means – it may be appropriate to consider whether exports to this country are justified.
The second element is proportionality – which means finding the right balance:
Member states and the Commission will consider the conditions prevailing in the country of destination, in particular the epidemiological situation, its vaccination rate and the existing availability of COVID-19 vaccines.
Of course, the important consideration to respect Advance Purchasing Agreement remains in place.
It is appropriate that we should distinguish between poorly performing companies and well-performing ones that are on track to meet their contractual obligations.
In addition, the new act includes some countries, previously exempted, in the scope of the regulation. The primary objective of this adjustment is to have more transparency on exports, and to obtain a full picture on what is happening outside the EU, so as to avoid possible circumvention of the rules.
Exports to low- and middle-income countries, supplies through COVAX and exports to EU overseas countries and territories remain unconditionally exempted.
The added value of this proposal is that it should allow us to arrive at a more cooperative approach with our partner countries, especially those in a less dire situation.
This will also help ensure the well-functioning flow of vaccine and ingredients to give predictability to companies to ramp up global production and safeguard a fair distribution of vaccines.
The regulation will help us to meet the expectations of EU citizens, while maintaining our responsibilities to our partners around the world.
The most important thing at this crucial moment is to stabilise and accelerate the delivery of vaccines.
Thank you.