European Union leaders met on the 25 March to discuss possible COVID-19 vaccine export measures in a bid to bolster the bloc’s roll out of vaccines to its citizens.

During a press conference following the summit, European Commission (EC) president Ursula von der Leyen focused on AstraZeneca (AZ), warning the company to ‘honour’ its contract with the EU before exporting vaccine doses to other countries, such as the UK.
“We have to and want to explain to our European citizens that they get their fair share,” von der Leyen said at the news conference.

She added: “The company (AZ) has to catch up, has to honour the contract it has with the European member states, before it can engage again in exporting vaccines.”

Although leaders did not support a complete ban of vaccine exports from the EU, they supported tightening export controls ‘in principle’, according to the BBC.

This includes including “the criteria of reciprocity and proportionality” as part of the EU’s vaccine export mechanism, said von der Leyen.

Prior to the summit, the EC and the UK issued a joint statement, announcing that they are working towards a ‘win-win’ situation over COVID-19 vaccine supply issues.

The EC and UK have been in discussions over what can be done to ensure a ‘reciprocally beneficial relationship’ between them regarding the COVID-19 pandemic and vaccine supplies.

The statement added: ‘In the end, openness and global co-operation of all countries will be key to finally [overcome] this pandemic and ensure better preparation for meeting future challenges.’

European countries including Germany, France and Italy are expected to resume administering the AstraZeneca/Oxford University vaccine after EU regulators deemed the jab safe to use following a careful review.

The European Medicines Agency’s safety committee PRAC concluded its preliminary review of the blood clot reports, confirming that the benefits of the AZ/Oxford vaccine continue to outweigh the risk of side effects.

The PRAC affirmed that the vaccine is not associated with an increase in the overall risk of blood clots, also referred to as thromboembolic events.

The committee did find, however, that the AZ/Oxford vaccine may be associated with very rare cases of blood clots associated with low levels of blood platelets (thrombocytopenia), including rare cases of clots in the vessels draining blood from the brain (CVST).

The EMA reviewed seven cases of blood clots in multiple blood vessels – disseminated intravascular coagulation (DIC) – and 18 cases of CVST.

The regulatory agency said that a causal link between these cases and the vaccine has not been proven, but is ‘possible’ and that this deserves further analysis.
Due to these preliminary findings, the PRAC will complete an additional review of these risks, including considering the risks with other types of COVID-19 vaccines.

AstraZeneca (AZ) has updated results from a phase 3 trial of its COVID-19 vaccine conducted in the US, and has reported a slightly lower efficacy rate than previously reported.

The analysis of the trial confirmed the vaccine efficacy, with the updated results showing a slightly lower efficacy rate of 76%.

The key secondary endpoint of preventing severe or critical disease and hospitalisation due to COVID-19 remained consistent at 100%.

AZ initially said that its Oxford University-partnered vaccine demonstrated a vaccine efficacy of 79% at preventing symptomatic COVID-19, as well as 100% efficacy at preventing severe disease and hospitalisation, based on an interim analysis.

In the updated results, vaccine efficacy increased slightly in the 65 years and older age group, with a new reported efficacy of 85% in this population.

Initially, researchers reported that the vaccine had an efficacy of 80% in participants aged 65 years and over.

After reviewing the initial COVID-19 vaccine trial data, the US data and safety monitoring board (DSMB) had some concerns and notified the US National Institute of Allergy and Infectious Diseases (NIAID), the Biomedical Advanced Research and Development Authority (BARDA) and AZ.

According NIAID, the DSMB was concerned that AZ may have included outdated information from the trial, which could have provided an ‘incomplete view’ of the efficacy data.

In response, AZ said it would engage ‘immediately’ with the DSMB to share the primary analysis with the up-to-date efficacy data.

Moderna has begun giving booster doses of its COVID-19 vaccine to trial participants as part of an amendment to a phase 2 clinical study.

The phase 2 trial amendment has enrolled 60 participants who have already received Moderna’s original mRNA-1273 vaccine. They will receive a single booster dose of a modified candidate addressing the B.1.351 variant or a multivalent booster candidate.

The variant-specific booster candidate – mRNA-1273.351 – encodes for the spike protein of the SARS-CoV-2 variant B.1.351, first discovered in South Africa.

Moderna will evaluate two doses of mRNA-1273.351 – 20µg and 50µg – to determine if this candidate can act as a booster to address and improve protection against the B.1.351 variant.

The study will also evaluate a 50µg dose of Moderna’s multivalent booster candidate – mRNA-1273.211 – which combines Moderna’s original vaccine with mRNA-1273.351 in a single vaccine.

In a previous protocol amendment, phase 2 study participants who had already been vaccinated with mRNA-1273 were given a single 50µg booster dose of the authorised vaccine.

Moderna has previously conducted in vitro studies using blood samples from individuals who had been vaccinated with mRNA-1273 and exposed to the UK and South Africa variants, to determine the level of protection that the jab offers against the new strains.

Moderna noted that there was a six-fold reduction in neutralising antibodies observed with the South African B.1.351 strain, although the company added that the levels induced by its vaccine should still offer protection.

The World Health Organization (WHO) has granted an emergency use listing (EUL) for Johnson & Johnson’s (J&J) one-dose COVID-19 vaccine for use in adults aged 18 years of age and older.

A WHO EUL is designed to enable potential vaccines to become available globally at a faster rate, by expediting access to products in many countries across the globe.

It is also a prerequisite to supply vaccines to the international vaccines-sharing facility COVAX.

COVAX is the vaccine pillar of the WHO’s ACT Accelerator – a collaborative initiative co-led by Gavi, the WHO and the Coalition for Epidemic Preparedness Innovations (CEPI) that is aiming to accelerate the development, production and equitable access to COVID-19 tests, treatments and vaccines.

In December 2020, J&J entered into an agreement in principle with Gavi to provide up to 500 million doses of its COVID-19 vaccine to the COVAX facility.

The company expects to enter into an advanced purchase agreement with Gavi that would see these doses provided to COVAX until 2022.

“From the beginning of the pandemic, we have worked to develop and deliver a vaccine that could protect the health of people everywhere, and today’s milestone represents significant progress toward ensuring global access to our single-shot vaccine,” said Alex Gorsky, chairman and chief executive officer of J&J.

Johnson & Johnson’s (J&J) single-dose COVID-19 vaccine has scored a conditional marketing authorisation (CMA) from the European Commission.

J&J submitted its vaccine for a CMA in the EU in February, basing the submission on top-line efficacy and safety data from the phase 3 ENSEMBLE trial.

The ENSEMBLE study was conducted in eight countries across three continents, with 44% of participants enrolled in the US, 41% in Central and South America and 15% in South Africa.

Across all participants from the different geographies, the vaccine was 66% effective overall in preventing moderate-to-severe COVID-19, 28 days after vaccination.

The data also demonstrated that the vaccine was 85% effective in preventing severe disease across all regions and showed protection against COVID-19-related hospitalisation and death, beginning 28 days after vaccination.

The CMA was issued on the same day that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the J&J vaccine to prevent COVID-19 in adults aged 18 years and older.

J&J said in a statement that it is aiming to begin delivery of its COVID-19 vaccine to the EU in the second half of April, and to supply 200 million doses to the EU in 2021.