Canadá aprobó su primera vacuna propia contra el covid-19 / Novavax’s COVID-19 vaccine approved for Canadians 18 and older

El director ejecutivo de Medicago, Takashi Naga, calificó la aprobación de Health Canada de su vacuna Covifenz como “un hito importante para el país en la lucha contra la pandemia”, y dijo que la compañía ya está “fabricando dosis para comenzar a cumplir con su pedido”

Por AFP -febrero 24, 2022

Canadá autorizó el jueves la primera vacuna concebida en el país contra el covid-19, anunciaron la firma biofarmacéutica Medicago, con sede en Quebec, y su socia GlaxoSmithKline.

El anuncio ocurre cuando más de 90% de los adultos canadienses ya recibieron dos dosis de otras vacunas, pero aproximadamente la mitad de la población aún no ha recibido una dosis de refuerzo.

El director ejecutivo de Medicago, Takashi Naga, calificó la aprobación de Health Canada de su vacuna Covifenz como «un hito importante para Canadá en la lucha contra la pandemia», y dijo que la compañía ya está «fabricando dosis para comenzar a cumplir con su pedido».

Ottawa había encargado por adelantado hasta 76 millones de dosis de Covifenz.

Vacuna de Canadá
El ministro de Industria, Francois-Philippe Champagne, dijo que el desarrollo de la vacuna también revierte décadas de reducción de las capacidades de biofabricación de Canadá, algo que la pandemia había dejado en evidencia.

«Esta es la primera vacuna covid-19 autorizada desarrollada por una empresa con sede en Canadá y la primera que utiliza una tecnología de proteína de origen vegetal», dijo un comunicado del gobierno.

Ottawa había aprobado el uso de otras seis vacunas contra el covid-19, incluidas las de AstraZeneca, Moderna y Pfizer.

Según Health Canada, los ensayos clínicos han demostrado que la vacuna Covifenz de dos dosis tiene eficacia de 71% para proteger a los adultos de 18 a 64 años de edad contra las infecciones por coronavirus.

Novavax’s COVID-19 vaccine approved for Canadians 18 and older

U.S. company struck deals with several governments early in 2020 but had encountered myriad issues

Novavax’s COVID-19 vaccine has been approved for use in Canadians age 18 and older by Health Canada.

The approval of the vaccine, known as Nuvaxovid, comes about 18 months after the federal government announced a deal to produce batches of it in Montreal.

Health Canada is recommending the interval for the two-dose vaccine to be at least 21 days based on evidence from clinical trials.

Chief Public Health Officer Dr. Theresa Tam said at a briefing Thursday the first Nuvaxovid delivery is expected in March, arriving from India’s Serum Institute. Federal officials said they weren’t able to provide any clarity on the size or schedule of the deliveries.

Trial data involving about 45,000 people in multiple countries suggests the vaccine is more than 90 per cent effective in preventing severe illness and death.

The trials conducted by Novavax as part of its regulatory filing took place when the Alpha variant of the coronavirus was predominant, and Health Canada says Novavax will be “required to provide data regarding protection against current and emerging variants of concern, when available.”

Novavax has conducted trials of its vaccine for use in teens when Delta was the dominant variant but has not yet filed for authorization for younger age groups.

Health Canada’s chief medical adviser, Dr. Supriya Sharma, said that the company had also submitted lab-based studies that, while “imperfect” compared to clinical trials, show that neutralizing antibodies are formed by the vaccine for Omicron variant infections.

The National Advisory Committee on Immunization is advising the Novavax vaccine can be utilized for a primary series or a third dose for “people who have been unable, due to contraindications, or not willing to receive an mRNA COVID19 vaccine.”

The most common potential side effects of the vaccine are said to be in line with what has been documented with the four previously approved COVID-19 vaccines in Canada: soreness at the injection spot, chills, fatigue, muscle and joint aches, nausea and headaches.

Beset by delays
As it did with several other companies, the federal government struck a deal with Novavax early in the pandemic, with Canada agreeing to purchase 52 million doses.

Subsequently, it was announced that Novavax would produce its own COVID-19 vaccine at the National Research Council (NRC) site in Montreal.

“We expect that there’s going to be a circulation of this continuing through 2022 and 2023,” John Trizzino, the chief commercial officer and business officer for Novavax, said in an interview with CBC News in mid-2021.

“And so therefore, we think it’s important that we have enough production capacity in Canada to satisfy that.”

Sharma said Thursday that the facility has not yet reached the state where a site inspection is required, which would be a prelude to doses being produced there.

Novavax said in an email to CBC News that the company “continues to work with the government of Canada and NRC to transfer technology and validate the manufacturing of NVX-CoV2373, and development of this facility is progressing according to expectations.” 

Federal officials have said up to 24 million doses of vaccine per year could be produced at the Montreal facility. 

In the U.S., Novavax was one of the companies the Donald Trump administration placed an early bet on to produce vaccines, to the tune of a federal contract awarded in July 2020 that has been estimated at being worth $1.6-1.75 billion.

But the Maryland-based company encountered issues with respect to mass manufacturing its doses and fulfilling regulatory requests.

In late 2021, it gained an approval for use in Indonesia and ramped up its regulatory submissions, including to Canada, Australia, the European Union, the Philippines and the United Kingdom. Australia, for one, began administering its first doses of the Novavax COVID-19 vaccine last week.

But even as recently as last week, it was reported that Novavax was having issues fulfilling orders where it has been approved.

The company has yet to deliver vaccine on its largest contract for 1.1 billion doses to COVAX — a global vaccine distribution program for poorer countries – which would make Novavax its third largest supplier, according to business data and analytics firm GlobalData Plc.

Canada has pledged both money and vaccine doses in the quest to get much of the world vaccinated.

However, it was not immediately clear if Novavax doses would eventually figure prominently in those contributions, given how far along Canada is in its domestic inoculation campaign. According to CBC tracking, 84.1 per cent of the eligible population over five years of age is considered fully vaccinated while 46.6 per cent have received a booster dose. CBC News