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Red flags over AstraZeneca, J&J deal new blow to vaccination drive

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(FILES) In this file photo taken on July 21, 2020 a general view is pictured of the offices of British-Swedish multinational pharmaceutical and biopharmaceutical company AstraZeneca PLC in Macclesfield, Cheshire. Pharmaceutical company AstraZeneca said on September 8, 2020 that it had “voluntarily paused” a randomized clinical trial of its coronavirus vaccine in what it called a routine action after a volunteer developed an unexplained illness. Paul ELLIS / AFP


• U.S., S’Africa, Denmark halt campaign
• Exercise goes on as NPHCDA vaccinates 1,043,737
• Benefits of COVID-19 vaccines outweigh risks,experts insist

More reports, which have established link between AstraZeneca and Johnson & Johnson (J&J) vaccines with rare blood clotting disorder may fuel vaccine hesitancy and rejection in Nigeria.

Indeed, what was a worrisome suspicion four weeks ago is now widely accepted: The AstraZeneca COVID-19 vaccine can, in very rare cases, cause a disorder characterised by dangerous blood clots and low platelet counts.

In Europe, at least 222 suspected cases have been reported among 34 million who have received their first dose of the vaccine. More than 30 have died. About nine in 10 million people have reported blood clots after taking Johnson & Johnson (J&J) vaccine while 39 people in 10 million have reported same after taking AstraZeneca.

The United States (U.S.) Centre for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) have recommended that the United States pause the use of Johnson & Johnson’s COVID-19 vaccine over six reported U.S. cases of a “rare and severe” type of blood clot.

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The six reported cases were among more than 6.8 million doses of the Johnson & Johnson vaccine administered in the United States. In South Africa, Health Minister, Dr Zweli Mkhize, on Tuesday evening announced the suspension of the Johnson & Johnson vaccine rollout in the country. Mkhize said the decision was taken following the Food and Drug Administration’s recommendation to temporarily pause the J&J vaccine programme in the USA.

In taking the decision, Mkhize said that the FDA recommendation should not be taken lightly. “Based on their advice, we have determined to voluntarily suspend our rollout until the causal relationship between the development of clots and the Johnson & Johnson vaccine is sufficiently interrogated,” he said.

Denmark also announced Tuesday that it would stop using the Oxford University AstraZeneca vaccine, becoming the first European country to do so over suspected rare but serious side effects. Despite recommendations from the World Health Organisation and European medicines watchdog to continue using the inoculation, “Denmark’s vaccination campaign will go ahead without the AstraZeneca vaccine,” Health Authority director Soren Brostrom said at a news conference.

Denmark was the first country in Europe to suspend the use of the AstraZeneca jab in its vaccination rollout. More than a dozen countries followed suit. All but a few have since resumed use of the vaccine after the European Medicines Agency (EMA) emphasized the benefits of the vaccine and deemed it “safe and effective.”

This development has dealt a fresh blow to the world’s vaccination drive. Though it is a small number of unusual clotting cases, but experts fear it will erode vaccine confidence.

Outside of the U.S., Johnson & Johnson said it would delay the rollout of its vaccine in Europe, where several countries were due to begin administering shots this week.

South Africa, which has been hit hard by a more contagious variant of the virus, has halted use of the Johnson & Johnson vaccine as a precautionary measure. Australia said it will not purchase any doses from the company, citing concerns over it being the same type as the AstraZeneca vaccine.

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The European Union ordered 200 million doses of the Johnson & Johnson vaccine in 2021 and authorized its use on March 11, but has not yet started widespread distribution.

An EU official said the European Commission is seeking “urgent clarification” from Johnson & Johnson over the company’s “unexpected” delays to deploy across Europe.

France said yesterday that it will move ahead with administering the 200,000 doses of the Johnson & Johnson vaccine it has received. The UK has ordered 30 million doses of the Johnson & Johnson vaccine, but has not yet authorized its use.

MEANWHILE, revelations that both the Johnson & Johnson and AstraZeneca vaccines may have rare side effects could also have enormous implications for low- and middle-income countries.

These two vaccines, which are cheaper and easier to store and transport than Pfizer and Moderna, are seen as crucial to immunizing developing nations. Both have pledged to sell hundreds of millions of doses through the COVAX initiative, a vaccine-sharing scheme affiliated with the World Health Organization.

The Johnson & Johnson news is particularly painful for South Africa, which was forced to ditch its AstraZeneca vaccination campaign in February after a small preliminary trial showed that the shots offered minimal protection against mild to moderate illness caused by the country’s dominant variant of the virus. The government quickly pivoted to the Johnson & Johnson vaccine, announcing that it had secured nine million doses at $10 a dose.

INTERESTINGLY, in Nigeria, the National Primary Health Care Development Agency (NPHCDA) and the National Agency for Food and Drug Administration and Control (NAFDAC) are yet to raise a red flag on AstraZeneca vaccine.

As at yesterday, a total of 1,043,737 have been vaccinated in the country with the first dose of AstraZeneca. All 36 states of the federation, including Kogi State that earlier hesitated in rolling out vaccination campaign have been reached. Lagos leads with 192,061, followed by Kano, 56,942; Kaduna, 55,604, and FCT, 44,098. The state with the least vaccination figure is Kogi, 5,568.

Critics say the blood clotting may be connected to how the Johnson & Johnson vaccine is an adenovirus vector vaccine, the same type as AstraZeneca’s coronavirus vaccine.

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The AstraZeneca vaccine is not in use in the United States, but has been authorised in more than 70 countries. The European Medicines Agency recently concluded that unusual blood clots with low blood platelets should be listed as “very rare side effects” of the AstraZeneca vaccine. While advising the public to look out for the signs of clots, the regulators said the benefits of the shot were still worth the risk.

The Minister of Finance, Zainab Ahmed, had mentioned that Nigeria would procure Johnson & Johnson vaccine, while announcing a supplementary budget, a situation that has raised many questions.

Reacting to these concerns, Chairman, Experts Review Committee on COVID-19, Prof. Oyewale Tomori, told The Guardian yesterday: “We have not yet bought the J&J vaccines, and it is still a pause in its use while investigations go on. So we wait for the outcome of the investigations and decide whether to go ahead and buy. Remember Oxford AstraZeneca too had the same issues, but benefits outweigh the risks. J&J may turn out the same.”

Has the country reported any adverse event with AstraZeneca? Tomori, who is also a virologist and pioneer Vice Chancellor of Redeemer’s University, said: “Not that I am aware of officially. Both NAFDAC and NPHCDA are in the best position to answer that.”

On the implications of these concerns over WHO-approved COVID-19 vaccines, Tomori said: “They are likely to increase vaccine hesitancy and possibly rejection. But we must continue to provide accurate information and interpretation to the public. The public must also report any adverse effect they experience to appropriate authorities.”

President, Pharmaceutical Society of Nigeria (PSN), Mazi Sam Ohuabunwa, told The Guardian: “Nigeria, I believe should go ahead cautiously. Which is to take extraordinary effort to monitor reactions. Secondly, Nigeria should study the report from the European countries and see if they can identify the groups most susceptible for the adverse response and perhaps exclude them from the vaccines.

“We cannot afford to ignore science but we also cannot afford to follow their official responses as genetic and racial differences do occur in populations. We are not aware of any such rare blood clots in Nigeria yet. A few side effects like pain; low-grade fever and fatigue have been reported. But these have been self-limiting and transient.”

He added: “When all is said, the pros more than outweigh possible cons. In the USA out of 6.8 million doses injected, only six people have reported the rare clot giving a ratio of one incident in one million cases. Very low ratio. You may have same response if you used placebo (water injection for example). So all these are essentially precautions. No cause for Alarm in my view.”

A consultant pharmacist and medical director of Merit Healthcare, Dr. Lolu Ojo, told The Guardian: “There is nothing on ground to show that Nigeria will buy the J&J vaccine. My conviction is that the relevant authorities, NAFDAC inclusive, will review all the available facts before deciding on exposing Nigerians to the J&J vaccine.”

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On whether the country reported any adverse event with AstraZeneca, Ojo, who is also the Director of Organisation, Nigeria Academy of Pharmacy (NAPHARM), said there is no report of any serious adverse events yet among the nearly one million people who had taken the vaccine in Nigeria.

On the implications of these concerns over WHO-approved COVID-19 vaccines, Ojo said: “There are genuine concerns about the vaccines in Nigeria and all over the world. The reported adverse events, blood clot, death, etc. are no flukes, but they are real life events.

President, African Fertility Society (AFS) and Medical Director, Medical Art Centre (MART) Maryland, Ikeja, Lagos, said: “The AstraZeneca is still better than no vaccine. We understand that in Lagos State, the rate of reported Adverse Events Following Immunisation (AEFIs) is very low. Of the over 200,000 persons vaccinated so far, serious AEFIs account for less than 20 while non-serious AEFIs are less than 400 including pain at injection site, general body ache.

“One would advice that those who can tolerate baby aspirin should take it after a meal for a couple of days after taking the vaccine. Many people who took Panadol after the vaccine did not experience any pain on the site of injection.”

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