The US Food and Drug Administration (FDA) has announced that it will publicly post reviews of data relating to emergency use authorisations (EUA) of COVID-19 vaccines.

In a statement, FDA commissioner Stephen Hahn revealed the transparency plans, adding that the agency’s drug and biological products centre will publish its reviews ‘to the extent appropriate and permitted by law’.

“Let me be clear on a crucial point – the issuance of an EUA is based on data and science. For an EUA to be authorised, FDA’s career scientists conduct a rigorous evaluation of currently available scientific evidence about a medical product,” said Hahn.

In October, the FDA released new guidelines detailing how it will grant EUAs for COVID-19 vaccines, which included a new advisory stipulating that data from phase 3 studies should include a median follow-up duration of at least two months.

A number of companies have released efficacy data for their COVID-19 vaccines, including Pfizer/BioNTech, Moderna and AstraZeneca.

The FDA has scheduled a meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss both Pfizer/BioNTech’s and Moderna’s COVID-19 vaccine candidates – taking place on 10 December and 17 December, respectively.

Although the FDA is not bound to follow advice given by members of the VRBPAC regarding the EUA applications, the agency tends to follow the recommendations of the expert panel.

“The FDA recognises that transparency and dialogue are critical for the public to have confidence in COVID-19 vaccines. I want to assure the American people that the FDA’s process and evaluation of the data for a potential COVID-19 vaccine will be as open and transparent as possible,” added Hahn.

AstraZeneca is on the up after announcing that its Oxford University-partnered COVID-19 vaccine candidate has shown promise in both older and younger adults.

According to a report from the Financial Times (FT), the vaccine candidate – AZD1222 – triggers protective antibodies and T cell responses in older age groups. Since the beginning of the pandemic, older adults have been identified as having a higher risk of hospitalisation and death from COVID-19 compared to younger people.

According to the US Centers for Disease Control and prevention (CDC), it can also prove more challenging to find a vaccine that is effective for older adults.

This is because older adults have more risk factors associated with developing severe symptoms from infectious diseases, and also because the immune system undergoes immunosenescence as individuals age.

Immunosenescence is the gradual deterioration of the immune system, which occurs as a natural part of ageing. This makes it harder for vaccine developers to create a shot which prompts a similar immune response between young adults and older adults.
In addition to the promising immune response in older adults, AZ also said that adverse responses were lower among the elderly, according to Reuters.

“It is encouraging to see immunogenicity responses were similar between older and younger adults and that reactogenicity was lower in older adults, where the COVID-19 disease severity is higher,” an AZ spokesman also told Reuters.

The COVID-19 R&D Alliance has enrolled the first patient in a trial testing therapeutic candidates from Amgen, UCB and Takeda.

The COMMUNITY trial is testing a number of drugs from members of the COVID-19 R&D Alliance, a cooperative of over 20 pharma and life sciences companies working together in the fight against the novel coronavirus.

As part of the alliance, members are sharing clinical trial data and real-world evidence, as well as crowd-sourcing early-stage candidates to identify mechanisms or treatments that could be effective against COVID-19.

The initial therapies set to be tested within the COMMUNITY trial are Amgen’s psoriasis med Otezla (apremilast), UCB’s investigational myasthenia gravis treatment zilucoplan and Takeda’s hereditary angioedema drug Takhzyro (lanadelumab).

These candidates have been selected based on their potential to suppress or control the immune response and resulting inflammation observed in patients with severe COVID-19.
Amgen’s Otezla has already entered the trial, while Takeda and UCB’s candidates are expected to enter within the coming weeks.

The COMMUNITY trial is testing therapeutic candidates in hospitalised COVID-19 patients, which includes patients who may require either ongoing medical care, supplemental oxygen, non-invasive ventilation, high-flow oxygen devices or invasive mechanical ventilation.
It is enrolling hospitalised intensive care unit (ICU) as well as non-ICU patients with the aim of gaining a broader understanding of the use of therapeutic interventions in hospitalised COVID-19 patients facing a range of symptoms.

The European Commission (EC) has announced a new supply agreement with German biopharmaceutical company CureVac for 405 million doses of its mRNA-based COVID-19 vaccine candidate.

In a statement, EC president Ursula von der Leyen said that “if the vaccine has proven safe and effective against COVID-19, every member state will receive the vaccine at the same time, on a pro-rata basis, and under the same conditions”.

According to Reuters, the deal includes access to an initial 225 million doses of CureVac’s vaccine, with the EC eligible to purchase a further 180 million.

On 3 November, CureVac announced that early data for its vaccine candidate, CVnCoV, suggested that the shot triggered an immune response in participants, including strong binding and neutralising antibody responses.

The vaccine also demonstrated early indications of functional T cells, confirming activation of cellular immune response, according to CureVac.

CureVac’s candidate, like Pfizer/BioNTech and Moderna’s respective investigational vaccines, uses mRNA technology, a relatively new research area.

The European Commission (EC) has secured up to 160 million doses of Moderna’s COVID-19 vaccine candidate mRNA-1273 after the vaccine hit the mark in a large-scale phase 3 study earlier this month.

Moderna’s mRNA-based COVID-19 vaccine is the latest vaccine to be secured following a series of deals made between the EC and vaccine developers.

Previous EU deals include an agreement for potential vaccines from AstraZeneca, Pfizer/BioNTech, Sanofi/GlaxoSmithKline, Johnson & Johnson and CureVac.

The EC is also in discussions with Novavax for a potential supply deal for its COVID-19 vaccine candidate NVX-CoV2373, which is expected to begin late-stage testing by the end of November.

“While restrictive measures can slow down the spread of the virus in this very difficult situation, we all know that only a safe and effective vaccine will provide a lasting, sustainable solution to this pandemic,” said EC president Ursula von der Leyen.

Moderna has also announced an amended supply agreement with the UK for an additional two million doses of its COVID-19 vaccine candidate on top of the already agreed upon five million doses.

Following the agreement for an additional supply of Moderna’s mRNA-1273, the UK has now secured seven million doses of the vaccine – enough for around 3.5 million people.
“Every week, we are getting more positive news about the range of vaccines in development, and thanks to the work of our taskforce the UK has pre-ordered hundreds of millions of doses from those companies most advanced in their work,” said Health and Social Care Secretary Matt Hancock.

“With a wide range of vaccine candidates in our portfolio, we stand ready to deploy a vaccine should they receive approval from our medicines regulator,” he added.

Johnson & Johnson (J&J) has launched a second phase 3 trial of a single-dose regimen of its COVID-19 vaccine candidate, JNJ-78436735.

The ENSEMBLE trial is set to enrol up to 60,000 participants worldwide, while another study, ENSEMBLE 2, will evaluate a two-dose regimen of the vaccine in up to 30,000 participants.

The initiation of the parallel studies – ENSEMBLE and ENSEMBLE 2 – comes on the heels of positive interim results of J&J’s ongoing phase 1/2a clinical study of the investigational vaccine.

Interim analysis from this early-stage study, which is evaluating both a single-dose and a two-dose vaccination regimen, showed that a single dose of JNJ-78436735 induced a ‘robust’ immune response and was also generally well-tolerated among vaccinated participants.

The ENSEMBLE 2 study will enrol participants in the UK, the US, France, Germany, Spain, Belgium, South Africa, Colombia and the Philippines.

The UK-based trial will be conducted in collaboration with the National Institute for Health Research (NIHR) and is expected to recruit 6,000 participants.

The trial is being conducted in the UK as part of a deal agreed in August, which included an initial supply agreement for 30 million doses of J&J’s vaccine. As part of this deal, the UK also agreed to co-fund the phase 3 ENSEMBLE 2 trial.

The ENSEMBLE study, on the other hand, is being initiated in collaboration with the US Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID).