Moderna has announced that its COVID-19 vaccine appears effective against new coronavirus variants discovered in the UK and South Africa (SA).

The in vitro studies used blood samples from individuals immunised with Moderna’s vaccine and exposed to the new variants, to determine if the jab could still offer protection.
According to Moderna, the results were promising – vaccination with its COVID-19 vaccine produced neutralising antibodies against both the UK and SA variants, known as B.1.1.7 and B.1.351 respectively.

In this early laboratory study, researchers observed no significant impact on antibodies with the UK variant, relative to prior variants.

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

The B.1.1.7 variant, first discovered in the UK, is believed to spread more quickly and easily compared to the original SARS-CoV-2 strain.

The SA variant, B.1.351, is thought to be more transmissible and has also been linked to higher viral load in infected individuals.

After observing a reduction in antibodies against the SA variant in its preliminary studies, Moderna said that it will be advancing a booster candidate against this particular strain.
The company is also testing an additional booster dose of its COVID-19 vaccine, to evaluate whether this could further increase neutralising antibodies against emerging strains.

A one-dose COVID-19 vaccine developed by Johnson & Johnson’s pharma division Janssen has demonstrated an overall efficacy of 66% in a phase 3 trial.
The phase 3 ENSEMBLE trial evaluated the efficacy and safety of the vaccine for protection against moderate-to-severe COVID-19.

The 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.
In the US, the efficacy rate was 72% while in Latin America and South Africa the vaccine was 66% and 57% effective, respectively.

In South Africa, J&J said that 95% of the COVID-19 cases observed in the study were caused by the newly discovered B.1.351 virus variant.

Although the vaccine is less effective against the B.1.351 variant that was first discovered in South Africa, J&J said that the jab was 85% effective in preventing severe disease across all regions studied.

Importantly, the one-dose shot could be rolled out with more ease and efficiency compared to other two-dose regimens.

J&J’s vaccine is estimated to remain stable for two years at -20°C and for at least three months at +2 to +8°C (standard refrigerator temperatures).

In a statement, the pharma giant added that it is planning to file for a US Emergency Use Authorisation (EUA) early next month.

Following authorisation, J&J will ‘immediately’ be able to start shipping doses of the COVID-19 vaccine.

A laboratory study evaluating Pfizer/BioNTech’s COVID-19 vaccine has found that the South Africa (SA) variant has only a ‘small effect’ on the jab’s efficacy.

The in vitro study, which was published on the preprint server bioRxiv, used blood samples from individuals vaccinated with the Pfizer/BioNTech vaccine and tested these against the key mutations in the UK and SA variants.

Researchers from Pfizer and the University of Texas Medical Branch (UTMB) engineered three viruses with the key mutations to test against the vaccinated blood samples.
According to this study, the blood samples from individuals vaccinated with the Pfizer/BioNTech vaccine neutralised all the SARS-CoV-2 strains tested.

However, the researchers did note that neutralisation against the virus with the three key mutations present in the SA variant was ‘slightly lower’ when compared to the other evaluated viruses.

Despite this slight reduction, Pfizer and BioNTech said that the slight difference is ‘unlikely’ to cause a significant reduction in the effectiveness of the vaccine.

In addition, results from another laboratory study of Pfizer/BioNTech’s COVID-19 vaccine have found that the vaccine should protect immunised individuals against the new coronavirus strain first identified in the UK.

The study – published on the preprint server bioRxiv – used the blood of 16 participants in Pfizer/BioNTech’s previously reported phase 1/2 trial of BNT162b2 to test for neutralisation of both the original SARS-CoV-2 virus strain and the new SARS-CoV-2 lineage identified in the UK – known as B.1.1.7.
Results from this study found that participants who had received the vaccine were able to produce antibodies that neutralised the new virus strain, meaning that “it is very unlikely that the UK variant viruses will escape BNT162b2-mediated protection”.

A UK trial of Novavax’s COVID-19 vaccine has demonstrated an efficacy rate of 89.3%, with the jab also found to be effective against the UK coronavirus variant.

The phase 3 clinical trial, conducted in partnership with the UK government’s Vaccines Task Force, enrolled more than 15,000 people aged 18 to 84, with 27% over the age of 65.

The first interim analysis is based on 62 PCR-confirmed, symptomatic COVID-19 cases. Within this case number, 56 cases were observed in the placebo versus six in the vaccinated group – resulting in a vaccine efficacy of 89.3%.

Only one severe case of COVID-19 occurred in the placebo group, while all the other cases were found to be mild or moderate.

In addition, preliminary analysis found that the UK variant was detected in over 50% of the PCR-confirmed cases – with 32 cases being caused by the UK variant, 24 by the non-variant and six ‘unknown’.

Based on this information, Novavax calculated that its vaccine is 95.6% effective against the original COVID-19 strain and 85.6% effective against the UK variant.
“Good news that the Novavax vaccine has proved effective in UK trials. Thank you to all the volunteers who made these results possible,” said Prime Minister Boris Johnson.

The European Commission (EC) has granted AstraZeneca (AZ) and Oxford University’s COVID-19 vaccine a conditional marketing authorisation (CMA) for use in people aged 18 years and older.

The European Medicines Agency (EMA) recommended the CMA on Friday, following an assessment conducted by its Committee for Medicinal Products for Human Use (CHMP) of all the available safety and efficacy data for the vaccine.

This included results from four clinical trials in the UK, Brazil and South Africa, which involved approximately 24,000 people in total.

However, the EMA focused on the efficacy observed in results from the studies based in the UK and Brazil, as the other two studies had fewer that six COVID-19 cases each.
The agency also concentrated on results involving people who had received a two-dose regimen of the vaccine, given between four to 12 weeks apart.

According to the EMA, these results showed a 59.5% reduction in the number of symptomatic COVID-19 cases for those who received the vaccine, compared to those who received a placebo – reflecting a 60% efficacy for the jab.

The EMA also noted that although there are not enough results in older participants (over the age of 55) to determine how well the AZ/Oxford vaccine works in this group, protection against COVID-19 in this population is still ‘expected’.

British drugmaker AstraZeneca (AZ) and the European Union (EU) have been unable to reach a resolution in an ongoing COVID-19 vaccine deadlock.

The dispute began after AZ said that it would reduce initial deliveries of its Oxford-partnered COVID-19 vaccine to the EU by 60% in the first quarter of 2021.

AZ said it aims to deliver 31 million doses to the EU in Q1. A senior official told Reuters that the reduction in anticipated deliveries is due to production problems.

Previously, around 80 million doses of the AZ/Oxford University vaccine were expected to be delivered by the end of March.

Following this, European Commission president Ursula von der Leyen announced that AZ will deliver nine million additional doses of the vaccine in the first quarter, with 40 million doses in total now expected to be delivered in this time frame.

Meanwhile, Pfizer/BioNTech also announced that deliveries of their COVID-19 vaccine to the EU have been temporarily reduced.

Pfizer said in a statement that shipments of the vaccine doses were being impacted by changes made to its manufacturing processes in order to meet its new production capacity goal.

“Although this will temporarily impact shipments in late January to early February, it will provide a significant increase in doses available for patients in late February and March,” the company added.

On 1 February, BioNTech provided an update, saying that it is ‘back to the original schedule of vaccine dose deliveries to the European Union’.

‘Pfizer and BioNTech continue to work toward increased deliveries beginning the week of 15 February, ensuring we will supply the full quantity of vaccine doses in the first quarter we contractually committed to and up to an additional 75 million doses to the European Union in the second quarter,’ the company added.