The Gaithersburg, Maryland-based pharmaceuticals firm, which earned emergency authorization for its vaccine in the EU on December 20, received the go-ahead from UK drug regulatory authorities in the UK today.
The President and Chief Executive Officer at Novavax, Stanley C. Erck, welcomed the EU’s decision, thanking the EMA for their thorough assessment.
Novavax approved by UK drug authority today
In a statement, Erck said that he welcomed “the European Commission decision reflecting the first authorization of a protein-based COVID-19 vaccine for the people of the EU… we look forward to playing a critical role in helping to address the continued threat of COVID-19.”
Greek health officials stated that the first batches of Novavax will arrive in Greece on February 21 and inoculations with the vaccine will begin in March.
General Secretary of Primary Healthcare Marios Themistokleous said on Tuesday that Greece is expected to receive 474,000 Novavax doses in February and March. The first shipment, comprising 168,000 shots, will be distributed to vaccine centers throughout the country.
Today, the Medicines and Healthcare products Regulatory Agency (@MHRAgovuk) has granted conditional marketing authorization of Novavax’ COVID-19 vaccine – the first protein-based #COVID19vaccine authorized for use in Great Britain. Learn more: https://t.co/nzOyUTbmGt pic.twitter.com/cqPpbt4COs
— Novavax (@Novavax) February 3, 2022
Like the Pfizer/BioNTech and Moderna shots, the Novavax product is also administered as two doses; however, it may appeal to a segment of society that is uncomfortable with mRNA-based vaccines since it is made in the traditional way, with a base made of protein.
As of Tuesday, over 7,760,000 Greek people, representing 73.8% of the entire populaiton, had been inoculated with at least one dose of a coronavirus vaccine.
Over 45%, or 4,880,000 citizens had gotten their booster shot, and as of earlier this week there were another 200,000 citizens who were awaiting an appointment for a shot.
Greece has seen spikes in the numbers of senior citizens who signed up for inoculations after imposing a fine on all those over the age of 60 who are unvaccinated.
Forced with deciding to get the shot or paying a hefty fine of $114.00 per month,many Greek seniors have decided to take the plunge and become vaccinated.
Prime Minister Kyriakos Mitsotakis defended the government’s decision to make vaccinations compulsory for all over 60-year-olds across the nation in an interview with Reuters in December.
“I am certain that we are following an effective policy,” Mitsotakis said, adding that the measure was “proportionate” given the lag in vaccination rates and the fact that the government had previously “tried every available means of persuasion to boost their number.”
With the measure due to be voted on in Parliament later the same day, the Prime Minister pointed out that unvaccinated elderly people currently made up 90 percent of patients occupying ICU beds in Greek state hospitals.
In a press release issued on December 20, the EMA announced that it recommended granting conditional marketing authorization for Novavax’s COVID-19 vaccine Nuvaxovid, which is known as Novavax, on people aged 18 and older.
“Nuvaxovid is the fifth vaccine recommended in the EU for preventing COVID-19. It is a protein-based vaccine and, together with the already authorised vaccines, will support vaccination campaigns in the EU Member States during a crucial phase of the pandemic,” the press release notes.
It also explained that the decision was taken after a thorough evaluation by the EMA’s human medicines committee, which decided that the Novavax vaccine is efficient and safe.
According to the EMA, two clinical trials which included over 45,000 people found that Nuvaxovid was effective at preventing coronavirus infections.
This is the fifth vaccine approved by the EMA after the first four, including Comirnaty from BioNTech and Pfizer, which was approved on December 21, 2020; Spikevax, from Moderna, which was approved on January 1, 2021; Vaxzevria, from AstraZeneca, which was approved on January 29, 2021; and the COVID-19 Vaccine produced by Janssen, part of Johnson & Johnson, approved on March 11, 2021.
The following vaccines are still under review by the EMA: Sputnik V, produced by Russia; Sinovac, produced by China; Vidprevtyn, made by Sanofi Pasteur; and VLA2001, produced by Valneva.
Commenting on the authorization of the Novavax vaccine President of the European Commission, Ursula von der Leyen, said that the move comes at a time when there is a great need to step up vaccination and the administration of boosters amid the spread of the Omicron variant.
“This is the fifth safe and effective vaccine of our vaccine portfolio, offering welcome additional protection to the European citizen against the pandemic. May this authorization offer a strong encouragement to everyone who has not yet been vaccinated or boosted, that now is the time to do so,” the President said.
The World Health Organization had also given emergency approval to Novavax on December 17.
In terms of travel, the approval of the vaccine means that entry into the EU will be permitted for people vaccinated with an expanded variety of vaccines, as many of the member states permit entry only for those vaccinated with vaccines that have been approved by EMA.
Novavax is the first protein-based COVID-19 vaccine to be authorized for all adults 18 and over in Great Britain. The Gaithersburg, Maryland firm and the U.K. Vaccines Taskforce previously announced an agreement for up to 60 million doses of the protein-based inoculation.
Authorization for the shot is based on data including an ongoing pivotal Phase 3 trial conducted in the U.K. with almost 15,000 participants.
“We are proud that Nuvaxovid will be the first protein-based vaccine option authorized by MHRA as the United Kingdom tackles this next phase of the pandemic,” said Stanley C. Erck, President and Chief Executive Officer of Novavax.
“We thank the agency for its thorough review process and are tremendously grateful to the clinical trial participants and trial sites in the U.K., as well as the Vaccines Taskforce, for their ongoing support and vital
contributions to this program.”