United States health authorities have recommended pausing the Johnson & Johnson COVID-19 shot over blood clot fears, with the company announcing it would delay its European rollout in a setback for global immunization efforts.
Out of nearly seven million Americans who have so far received the single-dose vaccine, six women between age 18 and 48 developed a rare type of clot in the brain, officials said.
One later died, while another is in critical condition.
US Food and Drug Administration scientist Peter Marks has said the disorder might be triggered by a rare immune response to the vaccine similar to that seen in a few hundred recipients of the AstraZeneca jab in Europe.
“We have made the decision to proactively delay the rollout of our vaccine in Europe,” J&J said.
US authorities are conducting a probe which could result in tough regulatory choices, such as restricting the J&J vaccine to older people.
People who have received the shot within the past three weeks were asked to report to their doctors if they experienced severe headaches, abdominal pain, leg pain or shortness of breath.
The White House said it was confident there would be no “significant impact” on vaccination plans in the world’s hardest-hit country, where almost half of all adults have now received at least one dose.
Meanwhile, in Germany, people under the age of 60 who have received a first dose of the Oxford-AstraZeneca vaccine will receive a different jab for their second dose, federal and regional health ministers said.
Germany has suspended the distribution of the two-dose vaccine to people under 60 due to concerns over a possible link to rare blood clot cases.
But while J&J paused output, Pfizer said it increased production and could deliver 10 percent more doses than expected to the United States by the end of May.
That would bring its delivery by the end of next month to 220 million doses, its CEO Albert Bourla said, adding that it can also “supply the full 300 million agreed on … two weeks early.”
New guidelines
In the Philippines, the Food and Drug Administration said Wednesday they expected to issue new guidelines in administering AstraZeneca COVID-19 vaccine this week.
FDA Director General Eric Domingo made the announcement six days after the FDA and the Department of Health ordered the suspension of administering AstraZeneca COVID-19 vaccine in the country to those aged 59 years old and below.
This was in light of the European Medicines Agency’s (EMA) findings of a very rare side blood clot as a side effect in 79 cases out of 20 million administered AstraZeneca jab.
Domingo said: “We are finishing the new guidelines today so we can release it this week.
“The WHO, Vaccine Experts Panel and National Adverse Events Following Immunization Committee said that AstraZeneca vaccine benefits outweigh the risks.
“We will be releasing guidelines for those who will be giving the vaccine, so they can properly advise those who will be getting the vaccine in terms of what symptoms to watch out for, so they would know when do they need to consult for this very rare possibility of a blood clotting event,” he said.
Based on FDA evaluation, AstraZeneca COVID-19 vaccine can be used for 18 years old and above and has an efficacy rate of 70 percent after the first dose—a rating that increases after the second dose is administered four to 12 weeks after.
About 525,600 doses of AstraZeneca COVID-19 vaccines have been delivered to the country, all of which were donated by the global initiative COVAX facility.
Sinovac clinical trial
After the start of two other COVID-19 vaccine clinical trials, Chinese company Sinovac might start its trial in May, the Philippine government’s vaccine expert panel said.
“This is really for the 60 years and above. That was the issue before that they do not have enough data,” Dr. Nina Gloriani, VEP head, said during a Department of Health virtual briefing.
While its emergency use authorization says that it is not recommended for those 60 years old and above, the Food and Drug Administration recently decided to revise this to allow the vaccine to be given to the elderly.
Gloriani said the recent decision took into consideration new data from abroad and the “totality of evidence.”
While not privy to the details, Gloriani said it has something to do with ethical concerns since the rollout of vaccines already started in the Philippines.
Gloriani said clinical trials are usually placebo-controlled, which means that a percentage of the participants will only be receiving a placebo vaccine that has no effect. This might raise concerns for participants who might want to really get vaccinated.
DOH assurance
The Department of Health reiterated Wednesday that no COVID-19 vaccine currently available in the country has caused any death nor COVID-19 infection.
The DOH, in its statement, cited experts from committees tasked to assess adverse events following immunization.
Health Undersecretary Maria Rosario Vergeire said a total of 24,823 suspected AEFI cases have been reported as of April 11.
Vergeire said, among those who received the Sinovac vaccine, nearly 7,000 reported experiencing non-serious AEFI while 164 people had “severe” reactions.
From those who got AstraZeneca’s vaccine, 17,503 minor and 206 “serious” AEFI were reported.
She assured the public that “all of these are being investigated.”
The Food and Drug Administration said that a serious AEFI was one that results in death, a life-threatening situation like anaphylaxis, in-patient, and prolonged hospitalization, persistent or significant disability, congenital anomaly or birth defect, or a medically important event.
Some of the most common AEFI are pain at the injection site, chills, chest discomfort, fatigue, and headache.
Vaccine brands
Health Undersecretary Maria Rosario Vergeire said experts still have no official recommendation on the use of different brands of COVID-19 vaccines on one recipient.
Vergeire, in an interview on GMA News’ Unang Hirit, said the mixing of vaccine brands is still being studied by experts.
She said there was no sufficient evidence to allow the mixing of different brands so far.
“As of now, that is not yet the recommendation of our experts. There is no evidence yet to say what would happen if we give a brand of vaccine different from the first dose,” Vergeire said.
Vergeire said experts still recommended using the same vaccine brand for the first and second dose on one recipient.
‘Immunized’ pilgrims at Mecca
Elsewhere in the world, South Africa also suspended its J&J shot rollout, delaying an already sluggish campaign which has so far only administered this vaccine.
But the European Medicines Agency said it was continuing to carry out its own investigation, and Canada’s Prime Minister Justin Trudeau said his country still expected its first shipment of the shot by the end of April.
More than 800 million vaccine doses have now been administered globally, according to an AFP tally.
The total number of virus deaths is approaching three million, as the World Health Organization warned infections are rising exponentially despite efforts aimed at stopping them.
Muslims around the world began Ramadan on Tuesday, with many countries facing virus restrictions.
Mosques in the world’s most populous Muslim-majority nation, Indonesia, are only be able to host people at a maximum of 50 percent capacity. Worshippers must wear masks and bring their own prayer mats.
In Saudi Arabia, mask-clad worshippers entered Mecca’s Grand Mosque in batches to perform the ritual of circling the sacred Kaaba, a cubic structure towards which Muslims around the world pray.
Only immunized pilgrims are eligible for permits to perform the pilgrimage and to attend prayers in the Grand Mosque during Ramadan, the hajj and umrah ministry announced.
Sputnik takes off in India
India was given a boost as it authorized Russia’s Sputnik V COVID-19 drug, in a bid to fight a record surge that has prompted officials to impose nighttime curfews.
The country on Monday reported more than 161,000 new cases – the seventh consecutive day that more than 100,000 infections have been recorded.
It has now surpassed Brazil to become the world’s second most affected country.
Meanwhile, the virus is spreading like wildfire in Latin America.
France has suspended all flights from Brazil to curb the spread of a new variant found there.
Brazil’s neighbor Argentina set a new record of 27,000 cases in one day on Tuesday.
“We are facing a great increase in the speed of transmission of the virus with the appearance of new variants,” said Analia Rearte with Argentina’s Society of Vaccination and Epidemiology after an emergency meeting with experts and top government officials. With AFP