Lawyer Wadi suggests COVID-19 vaccine should first be registered in Pharmacy Medicines and Poisons Act

* Holds the view that the COVID-19 vaccines are being administered as part of a clinical trial

* “Consent of a participant in writing is an indispensable requirement in the conduct of clinical trial”

* Ministry of Health contends that vaccine shall not be compulsory on Malawi health care workers

By Duncan Mlanjira

Former Director of Public Prosecution, Ismael Wadi believes that if the COVID-19 vaccines would be made mandatory for the pandemic’s frontline health care workers just as is being administered in other countries, then there is need to apply for registration of the vaccine under part IV of the Pharmacy Medicines and Poisons Act Cap 35:01 before it can be administered in Malawi.

He observes that under Section 38 of the Act — safety, efficacy and quality are amongst some of the crucial factors to be considered by Pharmacy, Medicines and Poisons Board — the country’s licensing authority.

Writing on his Facebook page, Wadi said: “The compulsory COVID-19 vaccination for nurses in the USA and UK is, in my opinion and with due respect illegal, arbitrary and unreasonable”.

“A law or a regulation or a directive or a proclamation to that effect is a serious contravention of the right to freedom of choice and the right not to be forced to be part of scientific experimentation.

“Consent of a participant in writing is an indispensable requirement in the conduct of clinical trial. I still hold the view that the present vaccines are being administered as part of a clinical trial as there is no proof of efficacy of the vaccine and its adverse effects.

“A number of medical professionals have expressed great scepticism on the safety, efficacy and long term possible permanent effects of the vaccine.”

He challenges if he could be “educated” on the pharmacology of the vaccine — how it works to treat or prevent COVID-19; if there is proven efficacy, its contraindications and how he can access a summary of the results of the clinical trials.

He also questions its possible side effects ie if they are (a) common, (c) very common, (d) rare and (e) very rare.

Thus he suggests that there is need for Malawi to apply for registration of the vaccine under part IV of the Pharmacy Medicines and Poisons Act Cap 35:01 before it can be administered.

“The application for a license of a medicinal product requires submission of particulars of medicinal product, pharmaceutical data, chemical detail (active and inactive ingredients), manufacturering data, raw materials data, final product data which includes control procedures, stability data which includes experimental results, biological data and toxicological data.

“Suffice to say that I have known the Pharmacy, Medicines and Poisons Board to be one of the most competent Boards and I trust that they would do the needful and in particular to pay close attention to information on clinical trials, efficacy and adverse effects.”

A debate was ignited and Charles Thupi posed the question: “Why should one gets a vaccine [yet they are telling us] to continue wearing a mask?”

To which another prominent lawyer, Reena Purshotam said this was because there are lots of people who are still refusing wearing masks in public places.

“My mask only reduces the risk of infection if you too are wearing one,” Purshotam said. “Secondly, a vaccine is not a guarantee that you will never get COVID-19, it just means that if you do get it, your body should be better equipped to fight the virus — this applies to all vaccines.

“Thirdly these are frontline health care workers who treat COVID-19 patients and are exposed to COVID-19 much more than ordinary members of the population. My cousin is an NHS nurse and she has to get tested for COVID-19 every three days.

“Also, until the disease is eradicated (if that’s possible) or we have sufficient held immunity, it is still necessary to wear masks to protect vulnerable members of our society who cannot be vaccinated e.g. the immunocompromised.

“We don’t wear masks just for ourselves but also to protect others,” she said.

Mphatso Buliyani observes that Malawians should be thankful that this pandemic hasn’t been as devastating as it has been in the western world, saying “the choice on whether to have the vaccine or not could have been a simple one ie a choice between to live in hope or fear”.

Imtiaz Mosam response was: “What is confusing is that this COVID-19 is mutating [and the] question is how many types of vaccines should one have to take? Plus what are the negatives or shall I  say side effects of these vaccines?

“Plus there’s no data or information about these vaccines. Will they really be effective or just a scam ? These are my views and I stand to be corrected,” Mosam said.

Mavuto Thomas, acting deputy director of Preventive Health Services for Heath Education Service Ministry of Health, said this a very healthy debate and as they are working towards the modalities of the vaccine, all these concerns would have been addressed and properly rolled over.

He assured the public that the Pharmacy, Medicines and Poisons Board is part of the process as well as making sure issues of public ethics and the law are addressed as well.

He said the vaccine shall not be compulsory on Malawi health care workers — well as the general public — but would be advised to undergo it if they so wish.

“Mind you, nurses and other technical health health care workers, are governed by several institutions, which from time to time advise their members to be administered of some vaccines as required for the profession.

“We shall go by that after extensive consultation with their governing institutions. No one, including the frontline COVID-19 nurses, shall be forced to undergo the vaccine but they are encouraged to do so for their own safety, that of the patients they encounter and also of the general public.”

Thomas said he could not comment on whether the other countries are making it compulsory but at the moment, the country’s health authorities are working around the clock in the fight against the pandemic, including making sure the vaccine is possible for those willing to be administered.

“At the moment, the target is on the very essential personnel that are on the frontline fighting this pandemic so that they are well protected in order to treat the general public better,” he said.

He alluded that having a COVID-19 vaccine might be made permanently compulsory for travellers just like it is with Yellow Fever.

Meanwhile, the fears of a second wave of the COVID-19 are now real as on New Year’s Day two new related deaths were recorded while 101 new cases registered in the past 24 hours of January 1.

A situation report from co-chairperson of the Presidential Task Force on COVID-19 said of the 101 cases, 32 are locally transmitted infections and 25 are currently admitted — 12 at Queen Elizabeth, 10 at Kamuzu Central, two at Mzuzu Central and one at Zomba Central hospitals.

From the 32 local infections, 15 are from Lilongwe, seven from Blantyre, three each from Balaka and Mzimba North, two from Nkhotakota and one each from Salima and Zomba.

From the new cases, 69 are imported with 66 identified at Mwanza border who came through buses from South Africa on December 26. Three of the imported were identified at Songwe border in Karonga.

The two deaths are from Lilongwe, bringing total number of deaths at 191 since April.

Going into December, new cases that were being registered were minimal and COVID-19 related deaths remained stagnant but on December 8, there was one new death, no new cases and the active cases were at 38.

Then the new cases started rising — 8 on December 12, 3 the next day, 4 on 14th, 10 on 15th, 11 on 16th, 47 on 17th, 10 on 18th, 5 on 19th, 8 on 20th, 41 on 21st and 46 on 22nd and 13 on 23rd.

On Christmas Eve, there were 16, on Christmas Day 62, and 4 on Boxing Day, 11 on Saturday the 27th, 23 on Sunday, 11 on Monday and 23 on Tuesday.

The figures then soared to 83 on Wednesday to 112 on New Year’s Eve, bringing the total active cases to 505 going into 2021 and now at 604.