EU regulators: AstraZeneca’s gains outdo risk

The European Union’s medicines regulator said Tuesday it was “firmly convinced” the benefits of AstraZeneca’s vaccine outweigh potential risks, insisting there was no evidence linking it to blood clots after several nations suspended the shot over health fears.

The suspensions have provoked intense debate over whether it was prudent to put AstraZeneca inoculations on hold just as vaccination campaigns were beginning to gather pace.

Experts at both the World Health Organization and the European Medicines Agency (EMA) met Tuesday to discuss the vaccine, with the European organization expected to publish conclusions Thursday.

While millions of doses of the vaccine developed with Oxford University have been administered, small numbers of people have developed blood clots, prompting countries including the EU’s three largest nations — Germany, France, and Italy — to suspend injections.

The EMA insisted that countries should continue using the vaccine.

“We are still firmly convinced that the benefits of the AstraZeneca vaccine in preventing Covid-19 with its associated risk of hospitalization and death outweigh the risk of these side effects,” EMA chief Emer Cooke said Tuesday.

Cooke noted however that the regulator was “looking at adverse events associated with all vaccines.”

France and Italy welcomed the news.

The preliminary statements from the EMA “are encouraging,” read a joint statement from French President Emmanuel Macron and Italian Prime Minister Mario Draghi.

French Prime Minister Jean Castex vowed he would be vaccinated “very quickly” with the AstraZeneca vaccine to give the public confidence in the jab if it is ruled as safe by the EU medicines agency.

Castex also said that new restrictions could be put in place for the Paris region, such as the weekend lockdowns already imposed in the Nice and Calais regions.

“We are in a worrying and critical situation and, clearly, measures of the type that have been used in other parts of the territory are on the table,” he told BFM TV in a live interview.

In Britain, which has administered more than 11 million AstraZeneca doses, experts see no evidence of more frequent blood clots among the inoculated.

Prime Minister Boris Johnson wrote in The Times newspaper that the shot “is safe and works extremely well.”

One British scientist argues that COVID-19 itself — and not the vaccine — could be to blame, as it was known to cause such problems. With AFP

The “very likely explanation of at least some of the clotting disorders seen are a result of Covid-19 rather than the vaccine”, said Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine.

“Hence, even if there were a problem, acknowledged to be very rare with the AZ vaccine, the overall benefit would be so much greater than any speculative harm,” he added.

Coronavirus deaths across Europe meanwhile passed the 900,000 mark, making it the worst-hit global region in absolute terms, according to an AFP tally.

In the world’s hardest-hit country, the United States, former president Donald Trump encouraged his Republican supporters — one of the main groups resistant to Covid-19 vaccines — to get their shots.

“I would recommend it,” Trump said in a late Tuesday interview on Fox News.

This was Trump’s most explicit endorsement for the national mass vaccination campaign since he left office in January.

Meanwhile, in Brazil the COVID-19 death toll broke another record: 2,841 people died in a 24 hours, authorities said Tuesday.

Brazil, where President Jair Bolsonaro appointed his fourth health minister since the pandemic began, has the world’s second highest Covid-19 infection rate after the United States.

More than 382 million doses of vaccine have been administered globally, the vast majority in wealthier countries while many poorer nations have yet to receive a single jab.

AstraZeneca’s shot, among the cheapest available, was billed as the vaccine of choice for poorer nations and the clot reports have had an impact beyond Europe.

Countries that have halted or delayed the rollout range from Indonesia and Venezuela to Sweden and the Netherlands.

But Canadian Prime Minister Justin Trudeau urged his citizens to get the AstraZeneca shot. A scientific committee advising the government even extended its recommendation for AstraZeneca’s jab to people aged 65 and over.

And Thai Prime Minister Prayut Chan-O-Cha was himself injected as his country lifted its own AstraZeneca suspension.

“I am an example today,” he said.

The pandemic spurred unprecedented efforts to develop vaccines, with a number of successful options now available.

On Tuesday Brussels sealed a deal to step up deliveries of 10 million doses of the Pfizer/BioNTech vaccine, now scheduled to arrive in the EU before July rather than in the third quarter.

And a new agreement for Germany’s IDT Biologika to help produce the single-shot Johnson & Johnson vaccine would offer Europe greater certainty, Germany’s economy minister said.

Health and regulatory officials in the Philippines said the country would continue using AstraZeneca’s vaccine as there was currently no indication that it caused the blood clots reported in some European countries.

Close to a million doses of the AstraZeneca vaccine will arrive on March 22.

The chairperson of the National Adverse Events Following Immunization Committee, Dr. Lulu Bravo, said that less than 2 percent or about 200,000 people who were given a COVID-19 vaccine had serious adverse events after receiving the shot.

Allergic reactions and hypertension are the most common AEFIs reported, she said.

Also on Wednesday, the Food and Drug Administration said it has canceled its inspection trip to Russia after the Gamaleya Institute submitted the documents required to apply for emergency use authorization (EUA) of its coronavirus vaccine Sputnik V.

A team from the FDA was supposed to fly to Russia to inspect Gamaleya’s manufacturing plant for Sputnik V.

“The inspection trip to Russia did not push through because last Friday the applicant submitted the required documents and those are being reviewed,” FDA chief Eric Domingo told GMA News Online.

Gamaleya filed an EUA application in January after withdrawing its bid to hold a clinical trial in the country.

Health Secretary Francisco Duque said the government aims to vaccinate 450,000 people against COVID-19 daily by next month.

After health care workers, indigent senior citizens are next in line as they are most vulnerable to severe to critical COVID-19.

“We’re looking at 4,500 vaccination sites with each site vaccinating 100 individuals. So we’re looking at 450,000 [vaccinations] per day…as soon as the vaccines come at around April,” Duque said in an interview on ANC’s Headstart.

Israeli Ambassador to the Philippines Rafael Harpaz, meanwhile, said 30,000 Filipinos in Israel, including migrant workers, students and staff of the Philippine Embassy there have received the two shots of the Pfizer COVID-19 vaccine for free.

Harpaz said even Filipinos with expired working permits were also given free vaccine shots.

With a population of 9.3 million, Israel has already vaccinated 5.2 million people, more than a half of its population, with at least one dose, while 4.2 million people have received both shots of the Pfizer COVID-19 vaccines.

As part of its vaccination campaign, Israel’s Ministry of Health (MOH) has vaccinated for free anyone who is in Israel, regardless of their citizenship status or whether or not they have insurance.

“Israel is thankful for the Filipino caregivers for helping the elderly and the disabled Israeli citizens during the COVID-19 outbreak. For many years, the Israeli government has been providing the Filipino caregivers with full access to the advanced medical services of our country,” Harpaz said.

“The free access to COVID-19 vaccine is another way of thanking them and ensuring their health and safety,” Harpaz said. – With AFP

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