Denmark’s Dumping of AstraZeneca COVID-19 Vaccine Raises Worry Over Jab

Denmark’s Dumping of AstraZeneca COVID-19 Vaccine Raises Worry Over Jab

…Nigerian Health Authorities Insist Vaccine is Safe Move by the Danish authorities, to dump the use of AstraZeneca COVID-19 vaccine, amidst isolated severe cases of blood clots and suspected deaths, in people who had previously been vaccinated against COVID-19, with the shot, has heightened worry over the safety of the jab. But the Nigerian health

…Nigerian Health Authorities Insist Vaccine is Safe

Move by the Danish authorities, to dump the use of AstraZeneca COVID-19 vaccine, amidst isolated severe cases of blood clots and suspected deaths, in people who had previously been vaccinated against COVID-19, with the shot, has heightened worry over the safety of the jab. But the Nigerian health authorities which project that 40 per cent of the population will be vaccinated this year, insist there’s no cause for alarm, maintaining that the vaccine is safe.

Denmark is completely halting the use of AstraZeneca’s COVID-19 vaccine, the Nordic country’s Health Administration Head, Soren Brostrom, said at a press conference in Copenhagen on Wednesday, disclosing that the vaccination campaign will continue without the shot from the British-Swedish company.

Denmark had temporarily suspended vaccinations with the AstraZeneca shot on March 11 as a precautionary measure and the country has not resumed them since then, even to a limited extent as other countries have done.

Last week, the British authorities recommended that the AstraZeneca COVID-19 vaccine should not be given to adults under 30 where possible because of strengthening evidence that the shot may be linked to rare blood clots, according to a report by the Associated Press (AP).

The recommendation came as regulators in the United Kingdom and the European Union emphasized that the benefits of receiving the vaccine continue to outweigh the risks for most people — even though the European Medicines Agency said it had found a “possible link” between the shot and the rare clots. British authorities recommended that people under 30 be offered alternatives to AstraZeneca. But the EMA advised no such age restrictions, leaving it up to its member-countries to decide whether to limit its use.

Several countries have already imposed limits on who can receive the vaccine, and any restrictions are closely watched since the vaccine, which is cheaper and easier to store than many others, is critical to global immunization campaigns and is a pillar of the U.N.-backed program known as COVAX that aims to get vaccines to some of the world’s poorest countries.

“This is a course correction, there’s no question about that,” Jonathan Van-Tam, England’s deputy chief medical officer, said during a news briefing.

Van-Tam said the effect on Britain’s vaccination timetable — one of the speediest in the world — should be “zero or negligible,” assuming the National Health Service receives expected deliveries of other vaccines, including those produced by Pfizer-BioNTech and Moderna.

EU and U.K. regulators held simultaneous news conferences last Wednesday to announce the results of investigations into reports of blood clots that sparked concern about the rollout of the AstraZeneca vaccine.

The EU agency described the clots as “very rare” side effects. Dr Sabine Straus, chair of its Safety Committee, said the best data was from Germany, where there was one report of the clots for every 100,000 doses given, although she noted far fewer reports in the U.K. Still, that’s less than the clot risk that healthy women face from birth control pills, noted another expert, Dr. Peter Arlett.

The agency said most of the cases reported were in women under 60 within two weeks of vaccination, though it was unable to identify specific risk factors based on current information. Experts reviewed several dozen cases that came mainly from Europe and the U.K., where around 25 million people have received the AstraZeneca vaccine.

“The risk of mortality from COVID is much greater than the risk of mortality from these side effects,” said Emer Cooke, the EMA’s executive director.

Arlett said there is no information suggesting an increased risk from the other major COVID-19 vaccines.

In a statement, AstraZeneca said both UK and EU regulators had requested their vaccine labels be updated to warn of these “extremely rare potential side effect(s).”

“Both of these reviews reaffirmed the vaccine offers a high-level of protection against all severities of COVID-19 and that these benefits continue to far outweigh the risks,” it said.

The EMA’s investigation focused on unusual types of blood clots that have occurred along with low blood platelets. One rare clot type appears in multiple blood vessels and the other in veins that drain blood from the brain.

“We are not advising a stop to any vaccination for any individual in any age group,” said Wei Shen Lim, who chairs Britain’s Joint Committee on Vaccination and Immunization. “We are advising a preference for one vaccine over another vaccine for a particular age group … out of the utmost caution rather than because we have any serious safety concerns.”

In March, more than a dozen countries, mostly in Europe, suspended their use of AstraZeneca over the blood clot issue. Most restarted — some with age restrictions — after the EMA said countries should continue using the vaccine.

Britain, which relies heavily on AstraZeneca, however, continued to use it.

Suspension Damaging for AZ

The suspensions were seen as particularly damaging for AstraZeneca because they came after repeated missteps in how the company reported data on the vaccine’s effectiveness and concerns over how well its shot worked in older people. That has led to frequently changing advice in some countries on who can take the vaccine, raising worries that AstraZeneca’s credibility could be permanently damaged, spurring more vaccine hesitancy and prolonging the pandemic.

Dr. Peter English, who formerly chaired the British Medical Association’s Public Health Medicine Committee, said the back-and-forth over the AstraZeneca vaccine could have serious consequences.

“We can’t afford not to use this vaccine if we are going to end the pandemic,” he said.

In some countries, authorities have already noted hesitancy toward the AstraZeneca shot.

“People come and they are reluctant to take the AstraZeneca vaccine, they ask us if we also use anything else,” said Florentina Nastase, a doctor and coordinator at a vaccination center in Bucharest, Romania. “There were cases in which people didn’t show up, there were cases when people came to the center and saw that we use only AstraZeneca and refused (to be inoculated).”

After the EMA announcement Wednesday, officials in Spain said AstraZeneca would be limited to people over 60 years of age, and Italy issued a similar recommendation.

Belgium’s Health Minister, Frank Vandenbroucke, declared a four-week ban on administering the AstraZeneca vaccine to people under 56, but said that would have little impact on the vaccination campaign, since few from that age group are in line to get the shots this month.

Earlier Wednesday, South Korea had said it would temporarily suspend the use of AstraZeneca’s vaccine in people 60 and younger. In that age group, the country is only currently vaccinating health workers and people in long-term care settings.

“For the vast majority of people the benefits of the Oxford AZ vaccine far outweigh any extremely small risk,″ said Dr. Anthony Harnden, the deputy chair of Britain’s vaccination committee. “And the Oxford AZ vaccine will continue to save many from suffering the devastating effects that can result from a COVID infection.”

No Side Effect

Nigeria’s National Primary Health Care Development Agency (NPHCDA) has said that since the country commenced its COVID-19 vaccination, no Nigerian has observed any adverse reaction, noting that all side effects reported by those who have taken the jab have been mild.

In a statement in Abuja, Executive Director, NPHCDA Dr. Faisal Shuaib, said,

“We are aware of precautionary concerns that have been raised regarding one specific batch of the AstraZeneca vaccine, namely ABV5300.

“We understand that investigations are being conducted to determine if the batch is in any way linked to an observed side effect.

“While we await the outcome of the investigations, it is important to clearly state that Nigeria did not receive any doses from the batch of vaccines with issues.

Shuaib said that the government is satisfied that the clinical evidence indicates that the Oxford-AstraZeneca vaccine is safe and effective.

“Our assessment is in line with countries such as Spain and the UK who have indicated that they will continue to administer the vaccine because it remains an important tool to protect against COVID-19.

“The safety of vaccines delivered to Nigeria is paramount to the Presidential Task Force on COVID-19. For this reason, it has enhanced multi-sectoral collaboration among stakeholders and technical entities such as the Federal Ministry of Health (FMOH), NPHCDA, NAFDAC, the WHO and UNICEF whose cooperation ensures the highest global standards are met for vaccines delivered to Nigeria before they are distributed to Nigerians. Clear, rigorous protocols are being followed to safeguard the health of Nigerians,” he noted.

According to him, “We are continuing to monitor the developments regarding the ABV5300 batch and will share further information as it becomes available.”

The NPHCDC boss encouraged Nigerians who were among those being prioritized in the current phase to continue their confidence and enthusiasm for the vitally important national vaccine program, saying “Together, we can save lives”.

Speaking to journalists shortly after she received a jab of the AstraZeneca vaccine at the NAFDAC headquarters in Abuja, the Director General of the agency, Prof. Mojisola Adeyeye said the agency conducted diligent study on the vaccine and confirmed that it’s safe and efficacious for use against COVID-19.

Accelerated Approval

Speaking on the agency’s acclerated approval of Astrazeneca vaccine, NAFDAC director general said that from the record of the clinical trials conducted by the manufacturers and the analysis done by the agency, it’s benefits outweigh the side effects.

As regards concerns about the side-effects, she said only few persons showed some allergy after taking the AstraZeneca vaccine.

She however said that it is advisable that anyone who gets the vaccine jab should wait for 45 minutes for doctors’ observation before leaving the clinic.

Adeyeye said that from all indications, AstraZeneca vaccine is generally safe for use.

On the Johnson and Johnson vaccines, Adeyeye said that COVID-19 vaccine is scarce at the moment due to the fact that rich countries have ordered for most of the available doses.

“For Johnson and Johnson, we don’t have the doses yet. I believe that we will do soon. But generally, there is difficulty in accessing COVID-19 vaccine mainly because the rich countries have paid up for it in billions of dollars. “So, they are the ones getting the vaccines now. If we get the doses, we will study it but we are not likely to get it until the second and third quarter of this year,” she said.

She explained that both AstraZeneca and Johnson and Johnson vaccines have same level of efficacy but that the only difference is that AstraZeneca is two doses per individual while Johnson and Johnson is only one shot.

“We are expecting other vaccines, such as the Russian and Pfyzer Biotech vaccines. We may not have a lot of the Pfyzer Biotech but as for Astrazeneca and the Russian vaccine we expect to get enough,” she said.

Nigeria, on March 2, took delivery of nearly four million doses of the Oxford-AstraZeneca COVID-19 vaccine as part of an overall 16 million doses planned to be delivered to the country in batches over the next few months. The vaccines are being provided by COVAX, an unprecedented global effort to ensure equitable access to COVID-19 vaccines.

Upon arrival, samples were handed to the National Agency for Food and Drug Administration and Control  (NAFDAC), for further examination.

Nigeria on Friday, March 5th commenced the vaccination, beginning with frontline healthcare workers who are often at the risk of exposure to infections being the first responders to patients.

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