EU clears J&J vax, says blood clots ‘very rare’

Europe's medicines regulator said Tuesday that blood clots should be listed as a “very rare” side effect of Johnson & Johnson’s coronavirus vaccine, but that the benefits of the shot still outweighed the risks.

The United States is expected to announce its decision on the single-shot J&J vaccine by Friday, as nations around the world urgently try to accelerate inoculation campaigns and revive their pandemic-ravaged economies.

The European Medicines Agency (EMA) assessment came as an EU official promised to have enough doses available to vaccinate 70 percent of European adults by the summer -- a boon for the continent’s sluggish rollout.

Europe’s Johnson & Johnson campaign was delayed after US health regulators said the shot should be paused over blood clot fears.

After reviewing isolated cases of clotting among people who received the vaccine, EMA’s safety committee said it found a “possible link” to the jab.

The regulator said its safety committee “concluded that a warning about unusual blood clots with low blood platelets should be added to the product information” for the J&J shot.

“This is a very rare effect,” EMA chief Emer Cooke told reporters. “But it also makes it very important for doctors and patients to be aware of the signs so that they can spot any concerns.”

Italy’s health authorities said that in light of the EMA ruling, the vaccine should be considered “definitively safe” but the country would prioritize its use for people aged over 60.

‘We remain confident’

Only two countries had started administering the J&J shot before it was paused -- the United States and South Africa -- with more than seven million doses given out so far, according to an AFP tally.

The vaccine was praised as easier to administer and transport than some of its rivals, because it requires just one dose and can be stored at warmer temperatures.

The EU approved the J&J shot on March 3 and started taking deliveries on April 19, but has not yet started administering it to people.

A top Johnson & Johnson executive said Tuesday he hoped for a speedy resolution to the current pause.

“We remain very confident and very hopeful that the benefit-risk profile will play out,” Chief Financial Officer Joseph Wolk told CNBC.

The J&J concerns follow similar reports of blood clots in a very small number of people who received the AstraZeneca shot.

Trained to recognize

Healthcare workers in the Philippines will be trained to recognize rare adverse events, after Johnson & Johnson COVID vaccine was allowed to be used in the country.

The Department of Health said it would ensure that health care workers would be trained to deal with adverse events after immunization (AEFI).

Like AstraZeneca, Johnson & Johnson’s vaccines were linked to rare blood clotting cases.

But despite this, the Philippine Food and Drug Administration has approved Johnson & Johnson’s emergency use authorization application.

“We need to train our health care workers so they can immediately recognize these adverse events among our citizens who will be vaccinated so we are on the safe side,” Health Undersecretary Maria Rosario Vergeire said during a virtual briefing, referring to those part of the vaccination teams nationwide.

Vergeire said experts and vaccine manufacturers were continuously studying the blood clotting events which are “very very rare side effects.”

Vergeire said among the adverse effects that need to be monitored after vaccination are anaphylaxis, venous thromboembolism, and vaccine-associated enhanced disease. With AFP

Anaphylaxis is a severe allergic reaction to vaccine or vaccination components. This can result in difficulty in breathing and other symptoms.

Venous thromboembolism or blood clots in veins can meanwhile result in serious illness or disability, according to the United States Centers for Disease Control and Prevention.

Meanwhile, simulations have shown that the NCR Plus can administer 120,000 shots of COVID-19 vaccines per day by June provided that there is a steady supply of vaccines, Vaccine czar Carlito Galvez Jr. said.

“Our supply chain experts have also provided some sort of simulations wherein the NCR Plus will have a 120,000 jabs a day with the requirement that the NCR should have a steady supply of 3.3 million (doses) monthly,” Galvez said in a joint hearing of the House Committees on Health and Trade and Industry.

Priority sectors

The National Economic and Development Authority has submitted its recommendations for the official list of priority sectors and eligible workers under the A4 priority group for COVID-19 vaccine deployment.

Acting Socioeconomic Planning Secretary Karl Kendrick Chua said in a statement released Tuesday night the government was working to ensure the equitable distribution of vaccines, which could help facilitate the gradual reopening of the economy.

“Given the scarcity of the current vaccine supply, NEDA has identified the sectors or groups that have high levels of interaction with the public, and are needed to ensure security, consumer and worker safety,” he said.

“By prioritizing these sectors, we are also indirectly protecting the millions who avail of their services,” Chua said.

As the lead agency for the Recovery Cluster of the National Task Force against COVID-19, NEDA has recommended the inclusion of around 12.8 million frontline workers from nine industries or sectors to the A4 priority group.

These sectors include accommodation; transportation including logistics services; public administration and defense; manufacturing of food, beverages, medical and pharmaceutical products; religious organizations; food service; financial services, except insurance; and basic and higher education.

NEDA said examples of eligible workers include commuter transport drivers or operators (land, air, and sea), food and small parcel delivery workers, market vendors, hotel and restaurant frontline workers, financial services frontline workers, and teaching personnel in educational institutions.

Public sector workers in charge of clearances, taxes, incentives, and field personnel of the Philippine Statistics Authority are also qualified.

In addition, overseas Filipino workers scheduled for deployment within two months may also be considered in the A4 group, as long as they provide a copy of their latest verified employment contract.

‘Not behind’

The Philippines is not lagging behind other countries when it comes to vaccinating its citizens, vaccine czar Secretary Carlito Galvez Jr. said Wednesday.

Galvez said the Philippines ranked fourth among ASEAN countries in the number of doses which have been administered to its citizens.

Indonesia ranked first, with over 17 million doses administered to its residents, followed by Singapore and Myanmar.

The data presented by Galvez was based on Bloomberg and reports from foreign service posts.

A total of 1,353,107 Filipinos have been inoculated against COVID-19 since the official rollout of the vaccination program in March.

More vaccinators

The P368 million from the Bayanihan To Recover As One Law (Bayanihan 2) is being used to hire more vaccinators for the government’s COVID-19 mass inoculation program, the Department of Health said.

“We have Bayanihan 2 funds valid until June 2021 and this is P368 million which we have given to our regional offices to hire COVID-19 vaccinators and this is up to June 31, 2021, but we are requesting the extension of Bayanihan 2,” Health Undersecretary Myrna Cabotaje said in a joint hearing of the House Committees on Health and Trade and Industry.

The DOH has 3,000 vaccinators hired and that the DOH is proposing to include the same provision in the proposed Bayanihan 3 Law.

The Bayanihan 2 Law has P165.5 billion funds for the government’s COVID-19 response.

The government is also mobilizing medical health workers assigned in the military and other government agencies. With AFP

Topics: Johnson & Johnson , coronavirus vaccine , blood clot , European Medicines Agency
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