The European Union’s drug regulator said Thursday it was recommending that an antibody medication developed by AstraZeneca be authorized to help some vulnerable people avoid getting sick with the coronavirus.
The European Medicines Agency said in a statement that it was advising the use of the new drug, sold as Evusheld, in people age 12 and over before they were exposed to COVID-19, to prevent future infections.
It is now up to the EU’s executive arm, the European Commission, to officially authorize the drug.
The U.S. Food and Drug Administration cleared the medication in December for people with serious health problems or allergies who can’t get adequate protection from vaccination. Britain authorized the use of Evusheld last week.
“When the antibodies in Evusheld attach to the spike protein, the virus cannot enter the cells to multiply and is unable to cause COVID-19 infection,” the EMA said. The agency said it had assessed data on the drug from more than 5,000 people and found Evusheld reduced the risk of infection by 77%, with protection estimated to last at least six months.
EMA said the drug’s side effects were mostly mild, with some people reporting reactions at the injection point. The agency noted that research was done before the emergence of the hugely infectious omicron variant and said that it was evaluating data to determine if a different dose might be needed.
Although antibody drugs have been a standard treatment for treating COVID-19 infections for more than a year, AstraZeneca’s is the first intended for long-term prevention against COVID-19 infection rather than as a short-term treatment.
People who could benefit from the antibody drug include cancer patients, organ transplant recipients and individuals taking immune-suppressing drugs for conditions like rheumatoid arthritis.
Zimbabwe has launched a new COVID-19 vaccination campaign that includes jabbing children aged 12 and above to rescue a drive faltering due to vaccine hesitancy and complacency.
This week schools in the southern African country have become vaccination zones with children in school uniforms lining up to get the injections.
Many parents say they support the vaccination drive to prevent schools from becoming centers of infection, although others remain skeptical.
“Let them get vaccinated, it will save us a lot of trouble. Maybe it will stop the constant closures of schools … the online lessons drain us each time the schools are closed,” said Helen Dube, a parent walking her 12-year-old daughter to a school in the crowded Chitungwiza town, about 30 kilometers (19 miles) southeast of the capital, Harare.
“Plus, if schools are safe then we are also safe at home,” she said, referring to instances when schools have become centers of virus infection.
Zimbabwe is gradually returning to its normal school calendar after two years of intermittent and sometimes prolonged closures due to waves of COVID-19 cases.
Adults are also being targeted in the vaccination campaign which will run until mid-May, according to Vice President Constantino Chiwenga, who is also the country’s health minister.
Zimababwe was one of the first African countries to give shots of COVID-19 vaccines, achieving higher rates than much of the continent.
About 23% of Zimbabwe’s 15 million people have received two jabs, mostly of the Chinese Sinopharm and Sinovac vaccines, far short of the government’s initial target of 60% by the end of 2021. President Emmerson Mnangagwa’s government now says it is trying to reach a goal of 70% of the eligible population by the end of July.
Just over 5,400 people in Zimbabwe have died from COVID-19, according to official figures, although the toll is likely much higher because of undiagnosed or reported cases, according to health experts.
The government says it has enough vaccine doses, including for booster jabs, but uptake has slowed in recent months as the number of cases and fatalities have slowed. Just over 8 million doses have been used out of more than 22 million in stock, according to government figures.
After experiencing difficulties in getting adequate supplies of vaccines, many African countries are now making concerted efforts to get shots into arms.
Kenya, Congo, Ethiopia and Nigeria have also launched mass vaccination campaigns.
While COVID-19 cases have declined across the continent since the peak of the omicron-driven fourth wave in early January 2022, Africa’s vaccination coverage remains far behind the rest of the world. About 201 million people or 15.6% of Africa’s population of 1.3 billion are fully vaccinated compared with the global average of 57%, according to the World Health Organization.
“While this progress is welcome, the pace of vaccination across the continent needs to increase nine-fold if we are to reach our target of vaccinating 70% of the population by June 2022,” Matshidiso Moeti, WHO’s regional director for Africa, said this month.
WHO plans to support mass vaccinations in Africa “in at least 10 priority countries to reach 100 million by the end of April,” according to a WHO statement.
Together Africa’s 54 countries have recorded more than 11.3 million cases, including more than 250,000 deaths, according to the Africa Centers for Disease Control and Prevention.
Poland is abolishing practically all of its COVID-19 restrictions next week, a government official said Thursday.
People will no longer be required to wear masks in indoor public spaces starting Monday, Health Minister Adam Niedzielski said. The only exception will be in medical facilities, where staff and patients will still need to wear them.
He said other measures being abolished include quarantine for some travelers arriving in Poland and home isolation for those living in households with those who test positive.
People who test positive will still be required to isolate at home.
The decision comes as the numbers of new infections have been falling.
“The most important element, however, is the situation in hospitals,” he said, explaining that the recent omicron-fueled wave led to fewer hospitalizations than earlier waves.
The company behind a COVID-19 vaccine touted as a key tool for the developing world has sent tens of millions of doses to wealthy nations but provided none yet to the U.N.-backed effort to supply poorer countries, a sign that inequity persists in the global response to the pandemic.
COVAX had planned to make available 250 million doses from Novavax by March, but the U.N. agency in charge of deliveries says the first shipments now likely won’t be made until April or May.
It wasn’t supposed to be this way. CEPI, one of the organizations leading COVAX, gave Novavax $388 million to fast-track the vaccine’s development, aimed at making the shot available in poorer countries as the pandemic was exploding two years ago.
The investment guaranteed COVAX the “right of first refusal” to the first Novavax doses, but the deal applied only to factories in the Czech Republic, South Korea and Spain, said CEPI spokesman Bjorg Dystvold Nilsson.
There are other factories that aren’t part of the deal — and their shots are going elsewhere.
The Serum Institute of India, the world’s largest vaccine maker, has manufactured millions of Novavax doses. According to India’s Ministry of External Affairs and the institute, more than 28.9 million of those doses were sent to the Netherlands in January and February, while Australia received about 6 million doses. Indonesia also received about 9 million doses in December.
Thousands of other Novavax doses were also shipped from a Netherlands factory to other EU countries.
“Whatever the reason, a vaccine that was believed to be highly suitable for poor countries is now in large part going to rich countries,” said Zain Rizvi, a drug policy expert at the U.S. advocacy group Public Citizen. “It’s tragic that in year three of the pandemic, we still cannot get the resources, attention and political will to solve vaccine inequity.”
The delay is the latest setback for COVAX, which has been repeatedly hit by supply problems and has missed numerous targets to share doses.
Last year, WHO’s director-general Tedros Adhanom Ghebreyesus decried the chasm in vaccine supplies between rich and poor countries as a “catastrophic moral failure.”
Vaccine availability has been improving in poorer regions recently, but logistical problems persist.
According to data from Oxford University, only about 14% of people in low-income countries have received at least one dose of COVID-19 vaccine. More than 680 million doses of COVAX-provided vaccines remain unused or have expired, according to government data.
Even with vaccine supplies improving, some officials were eagerly awaiting the Novavax vaccine in particular because it is easier to transport and store than some other coronavirus shots. They also hoped it might be more enticing to people skeptical of the AstraZeneca vaccine, which suffered through a botched rollout in Europe.
Countries including Zimbabwe, the Central African Republic and Kiribati were among those in line to be offered Novavax doses by March from COVAX.
Before the pandemic, Novavax was a small American company that had never brought any vaccine to market. Its shots have proven highly effective, but it is relying heavily on other companies to make them.
The company, struggling to scale up production, also has delayed delivery to other countries, including some in the European Union. COVAX is supposed to receive more than 1 billion Novavax doses.
In a statement, the Gaithersburg, Maryland, company acknowledged that it had yet to share any shots with the vaccines alliance Gavi, which fronts the COVAX effort, but said it stands ready to do so.
“We continue to work with Gavi to reach our shared goal of ensuring global access to our protein-based vaccine where it is needed most,” Novavax said.
Gavi suggested part of the delay is that the Novavax vaccine wasn’t authorized by WHO until December. Gavi said it planned to allocate Novavax in the future and was “in close touch with the manufacturer and expects the supply to be available for delivery when countries need it.”
Health officials also worry that the urgency to vaccinate people everywhere against COVID-19 has disappeared — especially as many countries roll back precautions and the world’s attention is diverted.
“Rich countries have moved on from COVID and everyone is fixated on the war in Ukraine, but COVID-19 remains an acute crisis for most people in the world,” said Ritu Sharma, a vice-president at the charity CARE.
She said COVAX was still desperately short of vaccines and that based on the current pace of vaccination, the world was still “years and years” away from immunizing enough people to stop future COVID-19 waves.
Other experts said it was incumbent on public health agencies to ensure their investments into vaccines would benefit poor countries and to be more transparent about what went wrong.
“Whatever the explanation is, it’s unsatisfactory,” said Brook Baker, an access to medicines specialist at Northeastern University. “The bottom line is that there are still a lot of unvaccinated people in poor countries and once again, they are at the back of the line.”
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
Total Doses Distributed = 699,566,225. Total Doses Administered = 558,918,245. Number of People Receiving 1 or More Doses = 255,001,325. Number of People Fully Vaccinated = 217,184,868.
COVID-19 vaccinations for the youngest children just might be a step closer.
Moderna intends to seek U.S. authorization for kid-sized shots, releasing early study results Wednesday that suggest the two small doses work in tots younger than 6. Within weeks, competitor Pfizer hopes to learn if three of its even lower-dose shots do, too.
Here’s what is known so far, and what’s next before the nation’s 18 million children under 5 can become eligible for vaccination.
MODERNA’S RESULTS
Moderna says tots as young as 6 months developed high levels of virus-fighting antibodies from shots containing a quarter of the dose given to adults. Full study results are yet to come but the early findings suggest the vaccine may protect against severe illness in kids just like it does in adults.
One complication: Moderna’s study was conducted during the omicron surge, and none of the COVID-19 vaccines protect as well against infection with that super-contagious mutant — at any age — as they do against earlier variants.
There were no severe illnesses in the kid study. But sure enough, the vaccine proved just under 44% effective at preventing milder infections in tots up to age 2, and nearly 38% effective in the preschoolers.
PFIZER’S STUDY
The vaccine made by Pfizer and its partner BioNTech is the only one currently available for children in the U.S. Those 12 and older get adult-strength shots and 5- to 11-year-olds receive a third of that dose.
Pfizer is testing even smaller shots, a tenth of the adult dose, for kids under 5. Early results showed two shots produced enough antibodies to protect babies and toddlers but fell short for preschoolers.
Children’s immature immune systems often require multiple doses of vaccines to properly protect against other diseases. So rather than testing a higher dose, Pfizer gave kids a third shot. Results are expected in early April.
WHAT’S NEXT?
Once the Food and Drug Administration has an application from one or both companies, it’s expected to publicly debate the evidence with its scientific advisers. If FDA authorizes shots for the littlest kids, the Centers for Disease Control and Prevention then will convene its own experts before recommending if all youngsters need them — or only those at higher risk from COVID-19.
While cases are dropping for now in the U.S., other countries are seeing increases. A lull could be “the best time to get immunized because then you’ll be protected by the time the next surge starts,” said Dr. Bill Muller of Northwestern University, a researcher for Moderna’s pediatric studies.
WHY DO KIDS NEED A VACCINE?
While COVID-19 generally isn’t as dangerous in youngsters as adults, some do become severely ill or even die. About 400 children younger than 5 have died from COVID-19 since the pandemic’s start, according to the CDC. The omicron variant hit children especially hard, with those under 5 hospitalized at higher rates than at the peak of the previous delta surge, the CDC found.
About 57% of those ages 12 to 17 have gotten two Pfizer doses so far, and 27% of those 5 to 11.
WHAT ABOUT MODERNA SHOTS FOR OLDER KIDS?
The FDA limits Moderna’s vaccine to adults although it’s used in kids as young as 6 in certain other countries. The FDA is looking into a very rare side effect — heart inflammation — that sometimes occurs in teens and young adults, mostly males.
Moderna is giving the FDA updated safety information that it says backs adult-size doses for 12- to 17-year-olds, and also is seeking authorization to use half that dose in 6- to 11-year-olds. Regulators are expected to consider all three age groups at once.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
