Moderna’s mRNA-based COVID-19 vaccine has shown promise in an early trial involving a small group of elderly participants, the company announced in a presentation today.

The biotech’s vaccine candidate, mRNA-1273, was tested on ten adults between the ages of 56 and 70, and ten adults aged 71 and older. Participants received two 100µg doses of the shot, administered 28 days apart.

The early results show that Moderna’s vaccine produced encouraging levels of neutralising antibodies and T cell responses in the elderly participants, with no serious adverse events reported in this patient group.

Moderna’s shot also produced superior antibody levels in study participants compared to the levels seen in recovered COVID-19 patients.

Neutralising antibodies, while not definite proof that a vaccine is effective, are important in early clinical development and are an indicator of efficacy against infectious diseases like COVID-19.
This news is particularly important given the concerns surrounding the efficacy and safety of COVID-19 vaccine in the older population, as the elderly are likely to have a weaker immune system than younger people.

Since the beginning of the pandemic, older adults were identified as having a higher risk of hospitalisation and death from COVID-19 than younger people.

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

Translate Bio has announced that its Sanofi-partnered experimental COVID-19 vaccine induced immune responses in animal studies, as they gear up to start human trials in November.

Translate cited presentation slides from Sanofi in a regulatory filing which showed that three doses of the vaccine were able to induce neutralising antibodies and T-cell responses against COVID-19 in animal studies.

The US-based biotech signed a deal with Sanofi in March to jointly develop a novel mRNA-based vaccine for COVID-19.

The Sanofi deal saw Translate gain the ability to leverage its mRNA expertise in a bid to discover, design and manufacture a number of SARS-CoV-2 vaccine candidates.

In June, Sanofi expanded its deal with Translate with an upfront payment of $300m in cash and $125m in an equity investment to broaden the original coronavirus vaccine deal.

The expanded deal also builds upon Sanofi’s initial agreement with Translate, signed in 2018, to partner on mRNA vaccines for infectious diseases.

While Translate is offering its specialist knowledge in mRNA-based technology, Sanofi is providing its own expertise in vaccine development, as well as support from its external research networks to advance vaccine candidates for further development.

Shares in Novavax jumped after the company reported that its coronavirus vaccine candidate NVX-CoV2373 induced immune responses in an early-stage clinical trial.

The results come from the phase 1 portion of Novavax’ phase 1/2 clinical trial, which evaluated the vaccine at two dose levels – 5µg and 25µg – with and without an adjuvant in 131 healthy adults between the ages of 18 and 59 years.

According to Novavax, NVX-CoV2373 produced high levels of antibodies against the SARS-CoV-2 virus, which causes COVID-19, after a single dose of the vaccine. Participants treated with Novavax’ vaccine also demonstrated higher levels of antibodies after two doses compared to the levels observed in recovered COVID-19 patients.

The company added that the addition of its Matrix-M adjuvant boosted the effect of the vaccine in the early-stage study. Antibody responses produced by NVX-CoV2373 were also highly correlated with neutralisation tiers, which demonstrates that a significant number of the antibodies were functional.

Although the vaccine was generally well-tolerated, some participants experienced local symptoms and systemic events, including headache, fatigue and myalgia (muscle pain).

Following the positive phase 1 results, Novavax will promptly begin the phase 2 portion of the vaccine at a number of sites in multiple countries to evaluate if NVX-CoV2373 can prevent SARS-CoV-2 infection or reduce the severity of COVID-19 in a larger pool of participants.

A study led by Imperial College London has discovered that critically ill COVID-19 patients receiving a standard steroid medication, hydrocortisone, had a better chance of recovery compared to those who did not receive the drug.

The study evaluated hydrocortisone in 403 patients with suspected or confirmed COVID-19, who required respiratory or cardiovascular organ support. The patient population included participants of mixed ethnicities in the UK, Ireland, Australia, the US, the Netherlands, New Zealand, Canada and France.

Patients were randomised to receive different treatment regimens – one group were treated with a fixed dose of 50mg hydrocortisone four times a day for seven days, a second group were treated with the steroid if their blood pressure dropped and a final group received no hydrocortisone.

The trial found that using the fixed dose of hydrocortisone caused a 93% improvement in patient outcomes, which included an improved chance of survival and reduced need for organ support. In the second group, steroid treatment improved patient outcomes by 80%.

Another study, dubbed the RECOVERY trial, was also investigating another type of steroid, dexamethasone, which also improved recovery in patients with COVID-19.

The findings from these studies were published in The Journal of the American Medical Association (JAMA), alongside two further clinical trials which also found that steroids improve outcomes for severely ill COVID-19 patients.

Although steroids are not believed to be useful in the early stages of COVID-19 infections, the pooled data shows that these medications have efficacy for patients whose condition has significantly worsened.

The UK government has reach two separate agreements with Johnson & Johnson (J&J) and Novavax for early access to their respective COVID-19 vaccine candidates.

The deals include an initial 60 million doses of Novavax’s vaccine and 30 million doses of J&J’s vaccine. J&J’s vaccine, Ad26.COV2.S, will be supplied on a not-for-drift basis during the emergency pandemic to the UK, while Novavax has not disclosed the agreed price for its candidate, NVX-CoV2373.

As part of the deal, the UK will co-fund a phase 3 clinical trial of J&J’s vaccine, which will evaluate a two-dose regimen of the shot. This study will run in parallel with another phase 3 trial investigating the single-dose regimen of Ad26.COV2.S.

The J&J agreement will also provide a further option for an additional purchase of up to 22 million vaccine doses for the UK.

J&J has already started a phase 1/2a human clinical trial of Ad26.COV2.S in the US and Belgium, which is evaluating both one- and two-dose regimens of the vaccine in over 1,000 healthy adults aged 18 to 55 years, as well as adults aged 65 and over.

Novavax will also conduct a phase 3 clinical trial of its vaccine candidate with support from the UK’s National Institute for Health Research (NIHR), and has partnered with FUJIFILM Diosynth Biotechnologies to manufacture certain components of the vaccine in the UK.

Russia has become the first country in the world to grant regulatory approval to a COVID-19 vaccine, ‘Sputnik V’.

The approval comes before large-scale phase 3 safety trials of the vaccine, which can take months, had been completed.

“Any problem with the Russian vaccination campaign would be disastrous, both through its negative effects on health, but also because it would further set back the acceptance of vaccines in the population,” said Francois Balloux, professor of com-putational systems biology at University College London.

The vaccine’s name refers to the first artificial earth satellite launched by the Soviet Union, with Putin likening the vaccine approval to Russia’s success in the Cold War space race.
Russian business corporation Sistema has said that it expects to start manufacturing and producing doses of the vaccine at a scale of about 1.5 million doses a year, with its products initially going to Russian doctors and teachers.

It added that the first batches of the vaccine are ready and will be supplied to regions in Russia soon.

The vaccine was developed by Moscow’s Gamaleya Institute, which has faced criticism after researchers and directors injected themselves with the prototype months ago, bypassing the usual process of initiating human trials.