Johnson & Johnson’s Vaccination Implementation Study Gets Regulator Nod In South Africa

South Africa’s drug regulator announced on Monday that it has given permission for an implementation study of the Johnson & Johnson COVID 19 vaccine. This clears the way for the beginning of its vaccination drive. It plans to inoculate health workers to start with.

South Africa has not yet started its vaccination drive. The government has now decided to go with Johnson & Johnson’s COVID 19 vaccine.

J & J’s Vaccination Implementation Study Gets Regulator Nod In South Africa

The decision comes in the light of a trial that showed that AstraZeneca’s double-dose vaccine is not effective in protecting against the new virus variant that is prevalent in the country.

The agency said to a news channel that it has given approval for Johnson & Johnson’s vaccine’s implementation study. It also added that it is studying its market application.

Implementation study works in the same way as the final phase of the trial. Here, the vaccine will be given to 350,000 to 500,000 healthcare professionals.

The first batch of the vaccine, 80000 doses will reach the country this week; the President said to the Parliament. Johnson & Johnson is the first company to apply to a local regulator to register its COVID 19 vaccine.

South Africa is the worst-hit country in Africa. It accounts for one-third of the entire continent’s rate of COVID 19 infections.

The country also accounts for nearly half of the deaths in the region. This, according to experts, happened because of the new variant of the virus namely 501Y.V2.

The country’s health products regulatory authority said that J&J has not applied for authorization of its emergency use there.

The application is known as Section 21 application. It is valid for six months. Such an application authorizes an unregistered product’s emergency use.

The company’s application for full market registration. However, is being reviewed as part of the rolling review approach.

This allows the regulator to review the vaccine as and when the data becomes available, the agency added. It has received the second batch of data. It is under review.

The process gets completed when four batches of data are reviewed. This is one of the several strategies the regulator uses to speed up the approval of any product.

In such an instance, it will do you well knowing how to prepare your body to receive the vaccine.

Remember, most of these recommendations don’t have the backup of a research. Still, the Internet is buzz with them. Given below are some of them:

• Avoid alcohol at least a day before receiving the vaccine.
• Have a painkiller or a medication for allergy. Avoid it if you are undergoing treatment for any ailment. There are also those who advise avoiding it because it may interfere with your immune response.
• Avoid exercising before the vaccine: Here too, there exists no scientific evidence. However, experts advise that you refrain from exercising two hours before and after the shot.
• Prepare your immune system: The earlier you start, the better it will be. For the vaccine to do its work effectively, you need a robust immune system. Include all the vitamins, protein and minerals required for your body. A health professional’s advice will help a lot here.
• Sleep well: The advice holds true for all vaccines. Try to sleep well the night before receiving the shot. If possible, take a full-day leave. The vaccine may produce certain minor side effects. A full day’s work may tire your body.

There is no need of any medication for most of us after the vaccine. The side effects, most of the time, are minor. They go on their own after a few days. Headache, chills and fever are the most common among the reported ones.