LONDON (UK) – Novavax Inc’s COVID-19 vaccine was 96% effective in preventing cases triggered by the original version of the coronavirus in a late-stage trial conducted in the United Kingdom, the company said on Thursday, as it inches near regulatory approval.
The company said that there were no cases of severe illness or deaths among those who got vaccinated, signalling that it could stop the adverse effects of new variants, which have arisen.
The vaccine was 86% effective in protecting against the more contagious virus variant first emerged and is now seen to be in prevalence in the United Kingdom, for a combined rate of 90% effectiveness overall determined by data from infections of both versions of the coronavirus.
Novavax shares soared 22% in after-hours trading to $229. They were trading below $10 on January 21, 2020, after the company made an announcement that it was manufacturing a coronavirus vaccine.
A smaller trial conducted in South Africa, where volunteers witnessed another newer, more contagious variant, the Novavax vaccine was 55% effective, based on people without HIV, however, still fully prevented severe illness.
Novavax Chief Medical Officer Filip Dubovsky said the performance in South Africa indicated that a case may still be there for employing it in areas where the South African variant is found to be on the rise.
Novavax is also manufacturing new formulations of its vaccine, which will help to guard against emerging variants. It has plans to begin clinical testing of these shots in the second quarter of this year.
The company expects to make use of the data to seek regulatory authorisation in various countries. It is not clear when it will urge for an authorisation from the US or if regulators will have a demand that it needs to complete an ongoing trial in the United States.
Novavax is looking forward to get data from a 30,000-person trial in the United States and Mexico by early April.
Dubovsky said that Novavax is still planning to apply for authorisation from UK regulators early in the second quarter of 2021.
The UK trial gauged the efficacy of the vaccine during a period, where a high transmission of the UK virus variant is witnessed widely.
With regard to the shot’s effectiveness in the South Africa trial, it declined to around 49% when the analysis took data from HIV-positive participants into account as well.
“Ultimately, they have to decide whether the data we can bring to the table is adequate or whether they would prefer to wait on data from our US study,” Dubovsky said on Thursday.
CEO Stanley Erck told recently that the drugmaker expects to have tens of millions of doses stockpiled and which are ready for shipping in the United States when it receives authorisation.
Novavax now plans to make its two-shot vaccine at eight manufacturing locations, which includes the Serum Institute of India.
If authorised, it would follow suit to three COVID-19 vaccines, which have previously gotten approval for use in Britain from Pfizer and partner BioNTech, Moderna Inc and the AstraZeneca shot developed with Oxford University.
The company has received $1.6 billion from the US government in providing funds for the vaccine trial and to secure 100 million doses.