Another vaccine approved for monkeypox treatment

Barely three weeks after the European Union (EU) approved the use of a smallpox vaccine Imvanex for treatment of monkeypox, the United States Food and Drug Administration (FDA), Thursday, also issued an emergency use authorization for Jynneos vaccine to increase the existing monkeypox vaccine supply.

In its latest authorisation, the FDA said the approved vaccine will enable healthcare providers to use the intradermal injection and this will increase the total number of doses available for use by up to five-fold.

It stated that the emergency use authorization allows for use of the vaccine in people who are 18 years and older, and in people seen to be at high risk of monkeypox infection.

Jynneos vaccine was approved in 2019 for the prevention of smallpox and monkeypox disease in individuals 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.

The FDA explained that the Jynneos monkeypox vaccine is administered under the skin (subcutaneously) in two doses, given 28 days apart, and also for individuals 18 years of age and older determined to be at high risk of monkeypox infection.

The vaccine is administered between the layers of the skin (intradermally) and two doses of the vaccine given 28 days apart will still be required.

“There are no data available to indicate that one dose of Jynneos will provide long-lasting protection, which will be needed to control the current monkeypox outbreak,” it said.

“In recent weeks the monkeypox virus has continued to spread at a rate that has made it clear our current vaccine supply will not meet the current demand.

“The FDA quickly explored other scientifically appropriate options to facilitate access to the vaccine for all impacted individuals. By increasing the number of available doses, more individuals who want to be vaccinated against monkeypox will now have the opportunity to do so,” said FDA Commissioner, Robert M. Califf.

In late July, this year, the European Union (EU) approved the use of a smallpox vaccine, called, Imvanex, for treatment of monkeypox.

A statement released by the pharmaceutical firm, Bavarian Nordic, said the European Commission has extended the marketing authorisation for the company’s smallpox vaccine, Imvanex, to include protection from monkeypox.

“The approval … is valid in all European Union Member States as well as in Iceland, Liechtenstein, and Norway.”

The European Commission’s authorisation follows a recommendation by the EU’s medicines watchdog, the European Medicines Agency (EMA).

However, under EU law the EMA has no authority to actually permit marketing in the different countries in the bloc.

The European Commission, which is the authorising body, takes legally binding decisions based on EMA’s recommendation.

Imvanex has been approved in the EU since 2013 for the prevention of smallpox.

It was also considered a potential vaccine for monkeypox because of the similarity between the monkeypox virus and the smallpox virus.

Monkeypox is less dangerous and contagious than smallpox, which was eradicated in 1980.

It would be recalled that in early July, this year, the World Health Organization (WHO) officially declared the monkeypox virus outbreak across the world as a global health emergency.

Declaring the monkeypox as global pandemic, the WHO Director-General Tedros Adhanom Ghebreyesu, said the disease is now designated as a public health emergency.

The monkeypox disease was previously considered an African traditional endemic outbreak by the world health body.

The disease is a rare viral zoonotic infectious disease transmitted from animals to humans that occur sporadically, primarily in remote villages of Central and West Africa near tropical rainforests.

The latest edition of the Nigeria Centre for Disease Control (NCDC) update for July, confirmed four deaths from the monkeypox disease in four states in country.

This is also as the centre said 157 cases of the infection has been recorded in across 26 states in Nigeria.

The NCDC disclosed this in its latest monkeypox situation report for Week 30.

Nigeria is one of the countries in Africa where the disease is endemic. The agency said from January 1 to July 31, 2022, four deaths were recorded in four states – Delta 1, Lagos 1, Ondo 1 and Akwa Ibom 1.

The report also showed that there were at least 413 suspected cases of the disease in the country. The report read in part, “There were 56 new suspected cases reported in Epi week 30, 2022 (25th to 31st July 2022) from 19 states – Ondo 13, Plateau 8, Lagos 6 Adamawa 4, Abia 3, Borno 3, Kano 3, Delta 2, Anambra 2, Bayelsa 2, Kwara 2, Akwa Ibom 1, Gombe 1, Imo 1, Nasarawa 1, Osun 1, Oyo 1, Rivers 1 and Taraba 1.

“Of 56 suspected cases, there were 24 new confirmed positive cases in Epi week 30, 2022 from twelve 12 states – Ondo 5, Kano 3, Lagos 3, Abia 2, Adamawa 2, Bayelsa 2, Kwara 2, Delta 1, Anambra 1, Gombe 1, Rivers 1 and Nasarawa 1.

“From 1st January to 31st July 2022, there have now been 413 suspected cases and 157 confirmed cases (105 male and 52 female), from 26 states – Lagos 20, Ondo 14, Adamawa 13, Delta 12, Bayelsa 12, Rivers 11, Edo 8, Nasarawa 8, Plateau 6, Anambra 6, FCT 5, Taraba 5, Kwara 5, Kano 5, Imo 4, Cross River 3, Borno 3, Oyo 3, Abia 3, Gombe 3, Katsina 2, Kogi 2, Niger 1, Ogun 1, Bauchi 1 and Akwa Ibom 1.

“4 deaths were recorded from 4 states – Delta 1, Lagos 1, Ondo 1 and Akwa Ibom 1. Overall, since the re-emergence of monkeypox in September 2017 and to 31st July 2022, a total of 925 suspected cases have been reported from 35 states in the country.”