Valneva will seek regulatory approval in the UK and European Union after its COVID-19 vaccine candidate performed well in phase 3 trials.

VLA2001, an adjuvanted COVID-19 vaccine from French vaccine company Valneva, has met both its primary endpoints in a phase 3 trial, resulting in higher levels of neutralising antibodies than seen with the AstraZeneca vaccine.

Cov-Compare is a pivotal phase 3 trial that involved more than 4,000 participants aged 18 years and older across 26 trial sites in the UK.

VLA2001 is an inactivated whole virus vaccine, employing a similar approach to the flu vaccine.

In addition to a strong immune response, VLA2001 also offers a tolerability profile that is statistically significantly better than AstraZeneca (AZ), with fewer adverse reactions reported, especially in the older population.

Valneva hit the headlines this summer when the UK government cancelled a €1.4bn vaccine contract citing contractual breaches, even though the vaccine is set to be manufactured in Scotland.

The UK health secretary Sajid Javid later clarified this, saying that VLA2001 would not be approved by the country’s regulator, the Medicines and Healthcare products Regulatory Agency (MHRA).

Valneva is sending data to the MHRA as part of a rolling submission for approval and has announced that it will do the same with the European Medicines Agency.

Results from the world’s first randomised, controlled COVID-19 vaccine booster trial show a third dose of Pfizer-BioNTech’s Comirnaty offers near-total protection from infection.

Top-line results show that a booster dose of Comirnaty, administered to 10,000 people over the age of 16 who completed the original two-dose regimen, restored vaccine protection against COVID-19 to the high levels achieved after the second dose.

The third dose – on average given 11 months after the second dose – resulted in a relative vaccine efficacy of 95.6% compared to those who did not receive a booster.

Recipients of the booster shot were followed up after 2.5 months on average, during which time there were five cases of COVID-19 in the booster group and 109 cases in the non-booster group.

The trial took place when the much more transmissible Delta variant of SARS-CoV-2 was the dominant strain circulating.

“These results provide further evidence of the benefits of boosters,” said Pfizer CEO and chairman, Albert Bourla.

He added that the results from the trial will be shared with the Food and Drug Administration, European Medicines Agency and other regulatory agencies worldwide.
Ugur Sahin, CEO and co-founder of BioNTech, emphasised that the booster dose “can help protect a broad population of people”.

Multiple subgroup analyses supported this, showing that the jab was effective across age, sex, race, ethnicity and comorbid conditions.

Merck & Co – known as MSD outside the US and Canada – has signalled that its $11.5bn acquisition of Acceleron may have hit a bump in the road, after the company withdrew its notification of the buyout in late October, although it stated it would refile it in early November.

Merck withdrew its Premerger Notification and Report Form, filed on 14 October, to give the Federal Trade Commission additional time for review. By refiling the form in early November, Merck then has ‘a waiting period applicable to the pending acquisition’ that will expire on 16 November.

Merck announced plans to acquire Acceleron at the end of September to boost its cardiovascular portfolio through lead candidate sotatercept – a potentially first-in-class therapy for pulmonary arterial hypertension in phase 3 trials – as well as with marketed anaemia drug Reblozyl (luspatercept-aamt).

The acquisition is expected to close in the fourth quarter of 2021.

The withdrawal of its notification was prompted by a campaign from hedge fund, Avoro Capital Advisors, which owns a 7% stake in Acceleron.

The group released a letter to shareholders claiming that Merck’s offer undervalued the company. ‘We expect that, by the end of 2022, Acceleron will have results from its phase 3 STELLAR trial that is enrolling the prevalent PAH population, which we believe will support a higher share price,’ wrote the investors.

The fund stressed that Merck would be a ‘great partner’ for Acceleron, so the problem was ‘not the fit’, rather ‘the timing and the price’.

The refiling allows anti-competition regulators at the FTC more time to review the offer and gives Merck more time to collect the required shares from Acceleron investors.

The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have both given the go-ahead for an expansion of the US booster programme against COVID-19.

The FDA has amended the emergency use authorisations for a third, booster dose of the Moderna vaccine and a booster for the single-shot Johnson & Johnson vaccine in vulnerable populations.

The Moderna booster can be offered to those who are 65 years or older or younger adults at high risk of severe COVID-19, at least six months after the second dose.

The indication for a booster to the single-shot Johnson & Johnson is wider, covering any adult who received the first shot and with a much shorter space of two months between the first single-shot and the booster.

J&J reported results from the phase 3 ENSEMBLE 2 study, which looked at giving a booster shot of the vaccine 56 days after the first, single-shot dose. The booster offered 100% protection against severe/critical COVID-19 and 94% protection against moderate to severe/critical COVID-19 in the US.

The FDA has also taken the advice of its advisory board over the use of ‘mix and match’ boosters. saying that Americans can now receive any of the available COVID-19 vaccines as a booster, regardless of which vaccine they received originally.

Using data from the MS PATHS network in the US, Germany and Spain, Biogen has announced results of a new analysis showing patients treated with its portfolio of multiple sclerosis (MS) therapies mount an effective antibody response to COVID-19 vaccination.

The data was presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

Researchers evaluated blood samples from 322 participants 28-90 days after their last COVID-19 vaccine dose.

Approximately 92% of participants in the analysis received an mRNA vaccine. MS PATHS data indicate that 100% of people with MS treated with natalizumab, interferons or fumarates achieved an antibody response following COVID-19 vaccination.

“This is part of a comprehensive plan to understand B and T cell activation in the context of people with MS on DMTs being vaccinated for COVID-19 and will add to efforts by researchers to gather this important data,” said Maha Radhakrishnan, Chief Medical Officer at Biogen.

Preliminary results suggest that anti-CD20 and sphingosine 1-phosphate (S1P) therapies may reduce the antibody response to COVID-19 vaccination. Data suggests that approximately 40% of people with MS treated with anti-CD20 and S1P disease-modifying therapies mount an antibody response to the COVID-19 vaccine.
For all other classes evaluated in the analysis, including the broad range of MS therapies offered by Biogen, the antibody response to vaccination is consistent with the response of patients not being treated with an MS disease-modifying therapy.

Regeneron Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) for priority review of REGEN-COV (casirivimab and imdevimab) to treat COVID-19 in non-hospitalised patients and as prophylaxis in certain individuals.

The BLA is supported by two positive phase 3 trials involving more than 6,000 patients that evaluated the efficacy and safety of REGEN-COV to treat non-hospitalised patients already infected with SARS-CoV-2, and to prevent symptomatic infection in asymptomatic household contacts of SARS-CoV-2 infected individuals (both uninfected and infected contacts).

In Europe, the European Medicines Agency (EMA) has accepted a Marketing Authorisation Application for review of the same antibody cocktail, known as Ronapreve in the EU, for use in certain people either as a treatment in infected non-hospitalised patients or as prophylaxis.

In May, detailed results from a phase 3 trial found that REGEN-COV significantly reduced the risk of hospitalisation or death by 70%, and also shortened symptom duration and reduced viral load in non-hospitalised patients with COVID-19.

The phase 3 trial evaluated REGEN-COV in 4,567 high-risk outpatients with COVID-19.
All participants in this trial had at least one risk factor for developing severe COVID-19, including chronic lung disease, obesity, cardiovascular disease or were at least 50 years of age.

In the US, REGEN-COV has not been approved by the FDA, but is currently authorised for emergency use to treat patients with mild-to-moderate COVID-19 who are at high-risk of severe disease or hospitalisation.