Published: 11:07, April 10, 2021 | Updated: 19:50, June 4, 2023
J&J COVID-19 vaccine under EU review over blood clots
By Agencies

This Dec 2, 2020 file photo provided by Johnson & Johnson (J&J) shows vials of the COVID-19 vaccine developed by the company in the United States. (PHOTO / JOHNSON & JOHNSON VIA AP)

GENEVA / SAO PAULO - Europe’s drug regulator said on Friday it is reviewing rare blood clots in four people in the United States who received Johnson & Johnson’s COVID-19 vaccine.

The European Medicines Agency’s safety committee has also been looking at how AstraZeneca’s COVID-19 vaccine is associated with very rare cases of unusual blood clots and said it was now reviewing reports of capillary leak syndrome in people given AstraZeneca’s vaccine.

Johnson & Johnson (J&J) said it was aware of the rare reports of blood clots in individuals given its COVID-19 vaccine, and was working with regulators to assess the data and provide relevant information.

“At present, no clear causal relationship has been established between these rare events and the Janssen COVID-19 vaccine,” the company said in an emailed statement.

Of the four serious cases of clotting and low platelets, three occurred in the United States during the rollout of J&J’s vaccine from its Janssen unit, the European Medicines Agency (EMA) said. That was in addition to one person who died from a clotting disorder reported in J&J’s clinical trial.

The US Food and Drug Administration said it is aware of a few reports of individuals who had serious blood clots - sometimes linked with low levels of blood platelets - after they received the J&J vaccine, and noted that these conditions can have many different causes.

World Bank

The World Bank Group will have committed US$2 billion in financing by the end of April for COVID-19 vaccines in some 40 developing countries, World Bank Managing Director of Operations Axel van Trotsenburg said on Friday.

The US$2 billion is part of a pool of some US$12 billion that the World Bank has made available overall for vaccine development, distribution and production in low-and middle-income countries, van Trotsenburg told a World Bank forum.

David Malpass, the World Bank's president, said in separate remarks to the lender's development committee that the bank expects this to expand to US$4 billion worth of commitments in 50 countries by mid-year.

But public health officials at the same forum warned that a race between the coronavirus and the vaccines meant to stop it could be lost if the pace of vaccinations in the developing world did not pick up.

Malta 

Aiming to revive its tourism industry and get ahead of rival destinations, Malta plans to offer foreign visitors a handout of up to 200 euros (US$238.10) each if they stay at least three days on the Mediterranean island this summer.

Tourism Minister Clayton Bartolo announced the scheme on Friday, saying that with most COVID restrictions expected to be lifted by June 1, tourists booking summer holidays directly through local hotels would receive the handout.

World Travel and Tourism Council data show the tourist industry directly and indirectly accounts for more than 27 percent of Malta’s economy, but the sector has been hammered by the COVID-19 pandemic.

The country attracted more than 2.7 million foreign visitors in 2019 but figures have fallen by more than 80 percent since the virus was detected in March 2020.

Bartolo said tourists booking accommodation at a five-star hotel will get 100 euros from Malta’s Tourism Authority, which will be matched by the hotel for a total of 200 euros.

In a similar arrangement, those opting for a four-star hotel will receive a total of 150 euros and those booking a three-star hotel will receive 100 euros.

The grant grows by 10% when bookings are made with hotels on the smaller Maltese island of Gozo, three kilometres north of the mainland.

“The scheme is aimed at putting Malta’s hotels in a very competitive position as international tourism restarts,” Bartolo said.

It is expected to benefit some 35,000 visitors.

WHO 

There is a “shocking imbalance” in the distribution of COVID-19 vaccines worldwide and most countries do not have anywhere near enough shots to cover health workers and others at high-risk, WHO Director-General Tedros Adhanom Ghebreyesus said on Friday.

More than 700 million jabs have been administered worldwide against the disease, but 87 percent have gone to high income or upper middle-income countries, with low income countries receiving just 0.2 percent, he said.

“On average in high-income countries, almost one in four people has received a COVID-19 vaccine. In low-income countries, it’s one in more than 500,” Tedros told a briefing.

The COVAX facility has delivered nearly 38.4 million doses of COVID-19 vaccines to 102 countries across six continents, six weeks after it began to roll out supplies, the GAVI vaccine alliance and WHO said on Thursday. It aims to deliver more than 2 billion doses this year but has faced delays.

“We hope to be able to catch up during April and May. The problem is not getting vaccines out of COVAX, the problem is getting them in,” Tedros said, decrying the scarcity of supply.

The AstraZeneca shot - the mainstay of the COVAX programme so far - has been hit by safety concerns after reports of blood clots in some recipients.

Italy 

Italy eased lockdown restrictions, lifting some curbs that have been weighing on the economy in the region surrounding Milan and across the country as the latest virus resurgence slows.

Health Minister Roberto Speranza will sign a decree later on Friday to shift six regions classified as high-risk “red” areas to medium-risk “orange” status, his office said in a statement.

Brazil

Brazil’s Sao Paulo state and the city of Rio de Janeiro are easing restrictions on hospitality businesses and other activities, authorities said on Friday, even as Latin America’s largest country continues to break its own grim records for daily COVID-19 deaths.

Sao Paulo will allow customers to pick up takeaway food from bars and restaurants starting on Monday, while professional sports games will be permitted without crowds, along with a series of other specific activities, Vice-Governor Rodrigo Garcia told journalists.

In the city of Rio de Janeiro, officials on Friday lifted a broad set of restrictions put in place in late March. Bars, restaurants and malls can resume in-person service, though beaches and parks remain closed and an 11 p.m. to 5 a.m. curfew remains in effect.

Daily deaths remain near historic highs in both Sao Paulo, Brazil’s most populous state, and Rio de Janeiro, the country’s second biggest city. Rio Mayor Eduardo Paes and Sao Paulo’s Garcia both pointed to decreased pressure on local hospital systems when discussing their decisions to ease restrictions.

Antonio Barra Torres, the head of Brazilian health regulator met with Russian Ambassador to Brazil Alexey Labetskiy to clarify pending issues for the approval of the Sputnik V vaccine. Torres addressed the requests for import and emergency use of Sputnik V, stressing the agency awaits the fulfillment of legal requirements to move ahead with the analysis.

In a separate videoconference with the Indian Ambassador to Brazil Suresh Reddy, Torres discussed ways for the regulatory agencies of both countries to collaborate and improve the exchange of information regarding the Covaxin vaccine.

Pfizer

Pfizer and its partner BioNTech SE said they would ask regulators in the US and elsewhere to allow use of their COVID-19 vaccine in adolescents ages 12 to 15.

The companies said in a statement that they had requested that the US Food and Drug Administration expand the vaccine’s emergency-use authorization and that they plan to request similar rulings from other regulators worldwide in coming days.

If the requests are granted, it could pave the way for many more schoolchildren to be vaccinated before the next school year.

ALSO READ: WHO: COVID-19 deaths in Europe surpass 1m

CureVac

CureVac NV could win European Union approval for its vaccine as early as May, sooner than expected, a German newspaper cited a company spokesman as saying.

“We’re already very far advanced in the third phase of clinical trials and are awaiting data for the final application package,” CureVac spokesman Thorsten Schueller told Augsburger Allgemeine. “We hope the approval will come in May or June.”

CureVac’s boosters include Elon Musk, who deleted a Twitter post on Friday saying that the biotech sounded to be “a few months away from regulatory approval.”

US

The US recorded 4 million vaccine doses on Friday, returning the pace of inoculations almost to the level before a post holiday lull, according to the Bloomberg Vaccine Tracker.

It was the third straight day of increases, with the seven-day average now at 3.03 million doses a day. So far, 179 million doses have been administered. At this pace, it’s estimated to take another 3 months to cover 75% of the population.

J&J

The US Centers for Disease Control is working with health departments in four states to evaluate symptoms experienced after Johnson & Johnson vaccinations but has “not found any reason for concern,” a spokeswoman said in a statement.

“Many people don’t have any side effects after COVID-19 vaccines, but some people will have pain or swelling at the injection site or fever, chills, or a headache,” spokeswoman Kristen Nordlund said. “These typically don’t last long and are signs that your body is building protection.”

She said the states are Colorado, North Carolina, Georgia and Iowa. The symptoms include “dizziness, light headedness, feeling faint, rapid breathing, and sweating.” She said the CDC “is aware of other instances of these symptoms occurring with the other COVID-19 vaccines.”

Ireland

People traveling to Ireland from a host of countries including the US and France will have to quarantine for 14 days from next week, the Irish health ministry said. From April 15, travelers from those countries will be met on arrival in Ireland and brought to a hotel for two weeks at their own expense. The quarantine can be shortened if a person tests negative after 10 days.

Ireland already requires passengers arriving from more than 50 countries to stay in these hotels, while travelers from other nations are required to have a negative test within three days of travel and self quarantine when they arrive. Overall 16 countries including Canada and Belgium were added to the list Friday, while three including Israel will be removed.

AstraZeneca

AstraZeneca’s vaccine has a “communication problem” rather than a “science” problem, Lauren Sauer, Johns Hopkins University’s associate professor of Emergency Medicine, said in a Bloomberg Radio interview. The vaccine could help in areas where there’s community spread, particularly among the elderly.

“This is just another tool in our toolkit and part of it is about the potential risk of these rare events,” Sauer said. “But we do know that it is overall safe and quite effective especially in our older population.”

Germany’s Paul Ehrlich Institute said it has now counted 42 cases of a rare type of brain blood clot in people who were vaccinated with the AstraZeneca shot. All but seven of the cases were in women aged 20 to 63, the drug safety oversight body said. Doctors also found low blood platelet counts in 23 of the cases. Eight people died.

France

France administered a record 510,267 vaccine doses on Friday, bringing the total number of shots given since the inoculation campaign began to 14.1 million. The country is speeding up vaccinations after a sluggish start as it battles a resurgence of the virus. The government reported 41,243 new cases and 301 deaths in the past 24 hours.

Germany

Germany’s first draft of an agreement between federal and state officials for unified nationwide lockdown rules to curb Covid-19 infections includes a nightly curfew and business closures, Business Insider reported.

A 9 pm to 5 am curfew would be triggered when local seven-day incidence rates rise above 100 infections per 100,000 people, according to the report.

Italy

Italy eased lockdown restrictions, lifting some curbs that have been weighing on the economy in the region surrounding Milan and across the country as the latest virus resurgence slows.

Health Minister Roberto Speranza will sign a decree later on Friday to shift six regions classified as high-risk “red” areas to medium-risk “orange” status, his office said in a statement.

Panama

Panamanian health authorities on Friday approved the emergency use of the CoronaVac vaccine developed by Chinese pharmaceutical firm Sinovac.

"It is one more opportunity for Panamanians, to have another vaccine here in the country and that more people can be immunized, and achieve herd immunity at some point," said Elvia Lau, director of the Health Ministry's Department of Pharmacies and Drugs.

Ethiopia

Ethiopia registered 1,851 new COVID-19 cases in the past 24 hours, taking the nationwide tally to 225,516 as of Friday evening, the country's Ministry of Health said.

Meanwhile, 33 new COVID-19-related deaths were reported across the country, bringing the national death toll to 3,111, said the ministry.

The East African country reported 1,193 more recoveries, taking the national count to 167,945.

According to the ministry, Ethiopia currently has 54,458 active COVID-19 cases, of which 895 are under severe health conditions.

The latest figures from the Africa Centers for Disease Control and Prevention show that Ethiopia's COVID-19 cases accounted for about 5 percent of the African continent's total.

Bolivia

Bolivia on Friday said it decided to keep its border with Brazil closed for another seven days to stop the spread of the novel coronavirus disease, especially the Brazilian variant of the virus considered to be more contagious and possibly more lethal.

Bolivia first closed its border with Brazil on April 2, with provisions for cross-border trade, and was to lift the ban on Friday.

READ MORE: Brazil COVID-19 deaths on track to pass worst of US wave

Ecuador

Ecuador reported on Friday 1,059 new COVID-19 infections and 39 more deaths in one day, bringing the cumulative figures to 342,678 cases and 12,247 deaths, the Ministry of Public Health said.

In its daily report, the ministry also registered four more "probable deaths" from the virus, to a total of 4,911.

Ecuador is seeing an increase in the number of COVID-19 infections, which has overwhelmed the hospital system.

Pichincha province, where the capital Quito is located, has the highest number of infections with 118,927, after adding 191 in the last day.

Chile

Chilean Health Minister Enrique Paris called for national unity on Friday after 9,171 new COVID-19 cases were registered in the last 24 hours, a record number and the first time the country exceeded 9,000 daily cases.

"We are living through a critical moment of the pandemic. The key word is prevention; I call for national unity," the official said during a brief press conference.

With this record, the total number of COVID-19 cases climbed to 1,060,421, while 129 more deaths were reported in the last day, bringing the total to 24,108.

Poland

The total number of confirmed COVID-19 infections in Poland exceeded 2.5 million on Friday, with the pandemic leaving over 57,000 dead, the country's health ministry reported.

With 28,487 new cases confirmed in a 24-hour span, Health Minister Adam Niedzielski said that the numbers seem to have started falling. He warned, however, that the sharp rise in cases one to two weeks earlier will now have its effect on hospital occupancy.

President Andrzej Duda said later on Friday that the number of available beds is rising as more people are leaving hospital. Around 3,300 beds with ventilators are occupied, which is stable from a week earlier.

Tunisia

Tunisian Health Ministry on Friday reported 2,010 new COVID-19 cases, raising the total number of infections in the country to 268,837.

The death toll from the virus rose by 43 to 9,179, the ministry said in a statement.

The number of hospitalized COVID-19 patients reached 1,897, including 392 in intensive care units, while the total number of recoveries reached 223,391, it added.

Cuba

Cuba reported 1,017 new COVID-19 infections in the last 24 hours, to again surpass 1,000 in one day, as well as five deaths, the Ministry of Public Health said on Friday.

With these figures, the accumulated totals rose to 84,532 cases and 448 deaths, according to the ministry's national director of hygiene and epidemiology Francisco Duran.

Havana, which reported 484 new infections, maintains the highest transmission rate at 347 per 100,000 inhabitants.

"We have lowered our guard in terms of risk perception," Duran warned, adding that "more rigorous measures" are needed.