Novavax Inc’s experimental COVID-19 vaccine is safe and nearly 90 percent effective at preventing infection, but possibly not against all variants, an interim analysis shows.
On Thursday, the Gaithersburg, Maryland-based company released results from two clinical trials, one held in the UK and the other in South Africa.
Both countries have seen highly infectious variants crop up in recent months that have spread around the world.
A third clinical trial being conducted in the U.S. is still in the process of recruiting participants and is not expected to reveal data for several months.
In the UK late-stage trial, just 62 of more than 15,000 participants fell ill, showing 89.3 percent efficacy.
Roughly half were infected with the UK variant known as B.1.1.7, and the vaccine appeared to be almost as effective in that group.
Results showed 95.6 percent efficacy against the originally circulating variant and 85.6 percent against B 1.1.7.
But in South Africa’s mid-stage study of about 4,000 participants, the Novavax shot was not as protective and was found to be just 49.4% effective its variant, 501Y.V2.
The news comes just hours after the U.S. reported its first known cases of the variant in two unrelated people in South Carolina and days after both Moderna and Pfizer said that their vaccines are also less effective against the South African variant.
In a late-stage UK study, the Novavax coronavirus vaccine was shown to be 89.3% effective at preventing COVID-19 infection. Pictured: Three potential coronavirus vaccines are kept in a tray at Novavax labs in Gaithersburg, Maryland, March 2020
However, the vaccine was just 49.3% effective against the South African variant in a mid-stage study conducted in the African country. Pictured: A volunteer receives an injection from a medical worker during the country’s first human clinical trial for a coronavirus vaccine at Baragwanath Hospital in Soweto, South Africa, June 2020
Novavax’s vaccine uses synthesized pieces of the surface protein that the coronavirus uses to invade human cells and spurs antibody production. Pictured: The Novavax logo is reflected in a drop on a syringe
In the UK trial, of the 62 people who contracted symptomatic COVID-19, 56 had received a placebo and six had received the vaccine.
Just one person had a severe case of the virus, and was in the placebo group.
Roughly half the people who contracted the virus had the UK variant, but it appeared to be just as effective against the variant as it was against the original virus.
Novavax, which has not produced a vaccine before, was one of six vaccine candidates to be given funding for research and development by the Trump’s administration’s Operation Warp Speed last summer.
However, no contracts were signed with the U.S. Department of Health and Human Services to supply doses of the vaccine.
Its shot contains synthesized pieces of the surface protein that the coronavirus uses to invade human cells.
The idea is that the protein will cause human cells to spur production of antibodies to fight the infection.
This technology is a more traditional method of administering vaccines compared to the newer technology in the Pfizer and Moderna vaccines that has never been used before.
‘We have the first trial – we are the first to conduct an efficacy trial – in the face of a changing virus,’ Stanley Erck, the president and CEO of Novavax, said, according to The New York Times.
Erck said he expected the variants could alter the study’s results, but ‘the amount of change has been a bit of a surprise to everyone.’
It comes as the first cases of the South African variant were confirmed in the U.S. in two unrelated people in South Carolina within no travel history (above)
Dr Anthony Fauci, the nation’s top infectious disease expert, has said he is more concerned about the South African variant than any other. Pictured: Fauci speaks with reporters in the James Brady Press Briefing Room at the White House, January 21
The biotechnology company has been running trials in Britain, South Africa, the U.S. and Mexico.
However, the U.S.-based, late-stage trial did not begin until December after Novavax had issues in scaling up the vaccine’s manufacturing.
Novovax’s trial results raise the stakes for the Johnson & Johnson, which is expected to deliver its results next week after originally scheduled to do so this week.
This has led to rumors that the company found its vaccine was also less effective against the South African variant.
Dr Anthony Fauci, the nation’s top infectious disease expert, said on Wednesday he is more concerned about the South African variant than any other because of its mutations that might render vaccines less effective.
He added that data Johnson & Johnson, which has been testing its one-dose shot in South Africa, will be a bellwether for whether or not vaccines can protect against variants.
‘The South African and Brazilian variants are having this effect on the monoclonal antibodies’ in lab tests, Dr Fauci said during his first White House press briefing last week.
‘The real question is what is their impact on the vaccine?
‘We have to pay attention…[because] what they’re likely seeing is a diminution more with the South African variant than the UK variant in what would be the efficacy in the vaccine-induced antibody.’
In August, Novavax released Phase I trial data, which found its vaccine generated a an immune response higher than seen among COVID-19 survivors.
A total of 106 participants between ages 18 and 59 received the vaccine while 25 people were given a placebo at two sites in Australia.
The inoculation, named NVX-CoV2373, was given with or without an adjuvant, which is an agent that boosts the immune response.
Volunteers were split into four groups and given either five micrograms or 25 micrograms with or without the extra ingredient.
For those who were immunized, they were given the jab via intramuscular injection about 21 days apart.
Participants generated high levels of neutralizing antibodies and T-cells, both of which are needed to build up immunity.
It’s unclear how soon the vaccine would receive emergency use authorization from the U.S. Food and Drug Administration for distribution across the country.
Two South Carolina residents with NO travel history test positive for the South African ‘super-covid’-variant
By Natalie Rahhal, U.S. Health Editor
Two South Carolina residents are the first Americans with the South African ‘super covid’ variant that may make vaccines less effective, state health department officials confirmed on Thursday.
Neither person has a ‘known’ recent history of travel and they have no evident connection to one another, as far as health officials can tell.
That’s a worrying signal that the 50 percent more infectious variant has already been spreading silently in South Carolina, if not the broader U.S.
Both Moderna and Pfizer said this week that preliminary lab tests suggest their vaccines are ‘protective’ against the variant, but it does diminish the effectiveness of their shots.
Each company has said it is developing booster shots to improve the potency of their vaccines against variants, including South Africa’s.
It’s the second new variant reported in the US this week, after Minnesota confirmed the first American case of the P.1 variant from Brazil.
Variants from South Africa and Brazil contain similar mutations that may help them escape antibodies from vaccines, but the Brazilian form brings an additional worry.
The South African variant has a mutation in its spike protein (circled in yellow) that makes it more contagious, capable of reinfection and potentially more immune to vaccines
In the Amazon city of Manaus, people who should have been protected from reinfection are getting second bouts of COVID-19 as the highly infectious variant takes off and overwhelmed hospital there.
‘The arrival of the SARS-CoV-2 variant in our state is an important reminder to all South Carolinians that the fight against this deadly virus is far from over,’ said Dr Brannon Traxler, DHEC Interim Public Health Director.
‘While more COVID-19 vaccines are on the way, supplies are still limited. Every one of us must recommit to the fight by recognizing that we are all on the front lines now. We are all in this together.’
One person lives in the state’s easternmost ‘Pee Dee’ region, while the other is a resident of the ‘Lowcountry’ region to the south.
The two are both adults, but the state health department said that it will not release any further details of their identities to protect their privacy.
Neither person had a history of travel that the South Carolina health department was aware of, raising concerns that there are more cases in the US, and the variant has already been imported and begun spreading.