Gvt Finally Approves J&J Vaccine

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By Mary Taruvinga

THE Zimbabwean government has made a dramatic volte-face and urgently approved the use of the single-dose Johnson&Johnson Covid-19 vaccine.

Government had initially turned down donations of the British-made vaccine citing lack of storage facilities and a low efficacy rate, although watchers say the move could have been motivated by tit-for-tat motives after Washington extended sanctions on senior government and military executives.

The tug-of-war took over a month.

J&J is an American multinational.

The Medicines Control Authority of Zimbabwe (MCAZ) Wednesday announced the approval of the Britain manufactured vaccine, stating that the emergency use authorisation is valid for 12 months.

In June, the government had turned down a donation of three million doses from the African Union (AU) of the vaccine.

Finance Ministry permanent secretary George Guvamatanga then gave  as an excuse, the lack of preparedness on storage requirements.

Following the approval, the vaccine becomes the fifth to be approved for use in the country after the Chinese Sinopharm and Sinovac, the Russian Sputnik V and the Indian Covaxin.

Said MCAZ in a statement released Wednesday: “Based on the review of the submitted quality, safety and efficacy data and upon performing a benefit-risk assessment thereof, emergency use authorisation has been granted for Ad26.Sars-Cov-S manufactured by Johnson and Johnson. This authorisation was issued on the basis of section 75 of the Medicines and Allied Substances Control Act (Chapter 15:03).”

The vaccine is administered as a single dose of 5ml by intramuscular injection only.

It may be kept for 24 months unopened and is stored in a freezer .

Once removed from the freezer, it can be stored in a refrigerator at 2 to 8 degrees celsius, protected from light for a single period of up to three months not exceeding the expiry date .

Once thawed, the vaccine should not be refrozen.

MCAZ also said: “This emergency authorisation is valid for a period of a year or when the public health emergency ends.”

“If additional satisfactory data needed for full registration are submitted in an application to the authority, then full marketing authorisation (registration)  could be granted.”

In June, in a letter of rejection to the African Export-Import Bank, Guvamatanga had also expressed the government’s reservations about the vaccine’s possible side effects.

But clinical trials have shown that a single dose of the vaccine had an efficacy rate of 66% in the United States, and an even low efficacy rate in countries where more contagious variants are widespread.

Zimbabwe is currently battling to contain the rapidly spreading Delta variant and other highly prevalent coronavirus viral variants.

A recent study found out that the J&J vaccine has an efficacy rate of just 33% against the variant.

Currently, the vaccine has been authorised for emergency use by the European Union, the United States and other countries.

Janssen Pharmaceutica, a Belgium-based subsidiary of American company Johnson & Johnson, developed the vaccine in collaboration with Beth Israel Deaconess Medical Centre.

The AU set up the deal, in which the African Export-Import Bank would pay for 220 million doses of vaccines to be distributed equitably among member states.

Zimbabwe was to receive three million doses of the Johnson & Johnson vaccine that were produced in Britain.

The country is currently using China’s Sinopharm and Sinovac vaccines both from China, as well as Sputnik V from Russia and India’s AstraZeneca.

There has been high demand for Covid-19 vaccines in the country of late amid surging Covid-19 cases and deaths.