Novavax’s COVID-19 vaccine candidate has an efficacy rate of 96.4% against the original strain of SARS-CoV2. However, the efficacy rate drops up to 55.4% against the new B.1351 variant first identified in South Africa, and also spreading globally. 

The pharma company, which has never brought a vaccine to market before, published the data from two late-stage trials conducted in the United Kingdom and South Africa on Thursday.

The Phase 3 clinical trial conducted in the UK had over 15,000 participants, including 27% over the age of 65. The efficacy rate against the original SARS-CoV2 strain is on par with results from the Pfizer/BioNTech and Moderna vaccines. 

The efficacy rate reduced to 86.3% against the B.1.1.7 variant, first identified in the UK, and declined even further against the B.1.351 variant, initially detected in South Africa. 

The South African trial included two cohorts, one of 2,665 HIV-negative adults and the other of 240 HIV-positive adults. An analysis of both groups found an overall efficacy of 48.6%, but among HIV-negative participants, the efficacy rose to 55.4%. The majority of SARS-CoV2 cases in the trial were linked to the B.1.351 variant.

Although the efficacy was lower against both widespread variants, the vaccine candidate still demonstrated  “100%  protection against severe disease, including all hospitalisation and death,” across all arms of the trial, the company stressed.   

“We are very encouraged by the data showing that NVX-CoV2373 not only provided complete protection against the most severe forms of disease, but also dramatically reduced mild and moderate disease across both trials,” said Stanley C. Erck, CEO of Novavax, in a press release. 

“Importantly, both studies confirmed efficacy against the variant strains,” he added.

Leading COVID-19 Vaccines Have Reduced Efficacy Against New Variants

Novavax announced in January, after the release of the interim trial results, that it started developing a new version of the vaccine to target the more contagious and potentially more deadly variants. Clinical testing on the new vaccine will begin between April and June of this year.

Novavax joins Pfizer, Moderna, and AstraZeneca with results showing lower efficacy against the COVID-19 variants, specifically the B.1.351 variant. Moderna found a six fold reduction in neutralizing antibodies against B.1.351, Pfizer reported lower neutralization of the variant, AstraZeneca’s vaccine was minimally protective against mild to moderate infection from the variant, and Johnson & Johnson’s vaccine efficacy rate fell from 72% in the US to 57% in South Africa. 

The B.1.1.7 variant has been detected in over 90 countries by early March and the B.1.351 variant has spread to at least 48 countries. With the increased ability for the variants to evade the immune response triggered by the vaccines, new or updated vaccines will likely be necessary for sustained protection.

Sputnik V Vaccine Developers Question EMA’s Neutrality

Meanwhile, the developers of Russia’s Sputnik V COVID-19 vaccine accused the European Medicines Agency (EMA) of politicizing the vaccine approval process after a senior EMA official urged EU member states to postpone national rollouts of the vaccine until the EMA had completed its regulatory review.

In an interview last week, Christa Wirthumer-Hoche, chair of the EMA managing board, likened the use of the Sputnik V vaccine without a sufficient evaluation of the safety data to “playing Russian roulette.”

In response, the vaccine developers wrote on the Sputnik V Twitter account, “demand[ing] a public apology from EMA’s Christa Wirthumer-Hoche for her negative comments…, (which) raise serious questions about possible political interference in the ongoing EMA review.”  The EMA had not made any other such comments about other vaccines that it had reviewed, Sputnik’s developers noted. 

EMA did not allow such statements about any other vaccine. Such comments are inappropriate and undermine credibility of EMA and its review process. Vaccines and EMA should be above and beyond politics.
👇https://t.co/9jEK54jz83

— Sputnik V (@sputnikvaccine) March 8, 2021

The Sputnik V vaccine is currently under rolling review by the EMA.

The issue was quickly resolved by Thursday, but tensions are still present between the EMA, the Russian Direct Investment Fund (RDIF), the company responsible for marketing the Sputnik V vaccine abroad, and EU countries that are welcoming of the new vaccine.

Italy Becomes Latest EU Member State To Embrace Sputnik V

Italy, meanwhile, became the first country in the EU to sign a deal to produce the Sputnik V vaccine, with plans to produce 10 million doses of the vaccine in Italy by the end of the year. The deal was signed between Adienne, an Italian-Swiss pharma company, and Kirill Dmitriev, CEO of the RDIF, on Tuesday.

The production could start as early as July, if the vaccine is authorised by the EMA and Italy’s national medicines regulatory agency, AIFA. 

“The innovative production process will help create new jobs and allow Italy to control the entire production of the compound,” said the Italian-Russian Chamber of Commerce, which facilitated the negotiations. “This step will help solve the problem of the shortage of vaccine doses in Italy.”

Italy has significant business ties with China – and there has been longtime speculation that the heavy travel patterns back and forth between northern Italy and China may be one of the reasons why the Italy became the first European epicentre for the virus a year ago.

As for the Russian vaccine, a couple of EU countries have already moved forward with national approval and rollout, including Hungary, Slovakia, and Czech Republic. 

A RDIF spokesperson said on Tuesday that discussions also were underway with production facilities in Spain, France and Germany to manufacture the Sputnik V vaccine. A conversation on vaccine production cooperation was held between German Chancellor Angela Merkel and Russian President Vladimir Putin in January. 

Germany is reportedly “open to the idea of bilateral cooperation for the purpose of tapping European production capacities,” said Ulrike Demmer, deputy spokesperson for the German government. 

“Sputnik V is a very clever construct,” Thomas Mertens, head of Germany’s standing commission on vaccination, told Rheinische Post in an interview. “[It is a] good vaccine that will presumably also be approved in the EU at some point.” 

Proposed EU Vaccine Certificate Will Include Sputnik V and Chinese Vaccines

According to reports on the EU vaccine passport, the preliminary plans for which will be announced next week, the Sputnik V, Sinovac and Sinopharm vaccines will likely all be accepted as part of the certificate system, along with the EMA-approved vaccines. 

This system is designed to ease certain restrictions for individuals who have been inoculated, specifically for travelling between particular countries or within regions, in an effort to revitalize air travel and ease the pressure on economies.

Including the Chinese and Russian vaccines is being seen as a pragmatic move insofar as some EU countries have also authorised the Sputnik V, Sinovac, or Sinopharm vaccines for use, or are preparing to do so. 

Image Credits: Novavax, RDIF.