Why does the Novavax vaccine not arrive?
The councilor for health of Lazio, Alessio D'Amato, speaks of "yellow". Nuvaxovid, Novavax's vaccine, which was supposed to convince even the most resistant, still fails to be delivered. Here's why and what new arrival date we talk about
The European Medicines Agency (Ema) gave the green light last December 20 and two days later the Italian Medicines Agency (Aifa) also approved, but then Nuvaxovid, the Novavax vaccine that would have had to convince even the most suspicious , we have lost track.
Now, however, there seems to be a new delivery date.
HOW IT IS DONE AND HOW EFFECTIVE IT IS
Nuvaxovid, unlike mRNA vaccines (such as Pfizer / BioNTech and Moderna) or viral vector (such as AstraZeneca and Johnson & Johnson), is indeed a new generation vaccine, but it has a long history of studies and tests of safety and efficacy behind it.
In fact, protein vaccines include a type already in use for decades against diseases such as pertussis, hepatitis and meningitis, herpes zoster and other viral infections.
Protein vaccines, to provoke an immune response, provide cells with proteins and adjuvants, rather than a fragment of the genetic code. It is therefore a vaccine made at a biological level with recombined proteins.
Tests have shown Nuvaxovid to be over 90% effective in preventing serious illness and death.
WHO FINANCED IT
The US company Novavax, as part of the Warp Speed program – launched by former President Donald Trump to accelerate the development and production of vaccines – had received from the United States 1.6 billion dollars (more than any other investment in a manufacturer of vaccines at that time) to develop the vaccine despite never having marketed one before.
THE FORECASTS OF THE NOVAVAX CEO
On January 10, Stanley Erck, CEO of Novavax claimed that the first doses of Nuvaxovid had already been sent to Europe and that approval from many countries was expected within three months.
PROMISES NOT KEPT BY NOVAVAX
However, Novavax's predictions soon proved wrong. Reuters , in fact, writes that the company "has delivered only a small portion of the 2 billion doses it plans to ship worldwide in 2022 and has delayed first-quarter shipments to Europe and low-income countries such as the Philippines" .
DISCORDING VERSIONS
For its part, Novavax told the news agency that it had completed delivery of about 10 million doses in Indonesia and that several million more doses – without specifying the number – arrived in Australia and New Zealand on Monday.
However, an Indonesian official told Reuters that his country only received about 200,000 doses.
The company is said to be doing its utmost to deliver on its contractual commitments this quarter.
WHAT PROBLEMS ARE THERE
Amy Speak, a spokesperson for Novavax, reported that "some shipments have been held back by regulatory processes and are waiting in a distribution warehouse to go to health care providers."
Shipments to the European Union, Indonesia and the Philippines, we read on Reuters , have been held back by late regulatory approval by the World Health Organization (WHO), by the export restrictions of its manufacturing partner, the Serum Institute of India, and the delayed approval of individual vaccine batches by European regulators.
Novavax also has yet to fulfill its largest contract of 1.1 billion doses for the Covax vaccine fair distribution program.
HOW MUCH NOVAVAX SHOULD EARN
According to Refinitiv data, reported by Reuters , the company is expected to earn about $ 5 billion from vaccine sales in 2022, but analysts don't seem to be fully confident.
“It's worrying when they say they're ready to ship millions of doses, but the numbers they hear are different,” said Mayank Mamtani, health analyst at B. Riley Securities.
The stock market, meanwhile, has no patience and the company's shares fell by almost 10% in the first few trades.
IN WHICH COUNTRIES IT IS ADMINISTERED
To date, this vaccine is only in use in Indonesia, the first country to be authorized for emergency use.
IN WHICH COUNTRIES IT WAS AUTHORIZED
The UK had ordered 60 million doses of Nuvaxovid as early as November . However, it only approved it a week ago for people over 18 and the Guardian writes that it will not be readily available anyway as its use as part of the country's vaccination program will be considered by the Joint Independent Committee on Vaccination and Health. 'immunization".
The vaccine, CNN reports , has also been approved in South Korea, Australia, India and the Philippines where it should have started, but an official told Reuters that the country has not received any of the 30 million doses ordered. . Which is why the Philippines would be renegotiating their contract and considering reducing their order.
IN WHICH OTHER COUNTRIES COULD IT BE APPROVED
In the United States, home of the Novavax biotech, there is still no authorization from the Food and Drug Administration (FDA), to which the request for emergency use was submitted only on February 1.
The application was also filed in Canada and New Zealand.
BUT SO WHEN IT WILL ARRIVE
The Dutch National Institute for Public Health and the Environment, which is tasked with licensing the batches, declined to comment on the reason for the delay, but said the vaccine will be available in early March.
And once again the information does not seem to match, in fact, in Lazio, where the start of the administration of Nuvaxovid was scheduled for February 15, the councilor for health Alessio D'Amato said that he had not received more news on the Novavax vaccine .
"It has become a detective story, we have lost track – explained D'Amato – First we were told that it would be delivered in February, then in March, now they don't even tell us the times anymore …".
Yesterday, however, a spokesman for the EU Commission said that the first deliveries to Member States are expected on 21 February . Could this be the right time?
This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/perche-il-vaccino-novavax-non-arriva/ on Thu, 10 Feb 2022 09:37:18 +0000.