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The Pfizer-BioNTech vaccine was the first one granted authorization across the European Union in December, when it was given the green light for use in anyone 16 and over. Since then, about 173 million doses have been administered in the EU, which is about three-quarters of all vaccine shots given so far in the 27-nation bloc, according to Associated Press.
|In this Tuesday, Feb. 23, 2021 file photo, a sign is pasted into an upper window at Pfizer manufacturing center in Puurs, Belgium. The European Union cemented its support for Pfizer-BioNTech and its novel COVID-19 vaccine technology, Saturday, May 8, 2021 by agreeing to a massive contract extension for a potential 1.8 billion doses through 2023. (AP Photo/Virginia Mayo, File)|
“Extending the protection of a safe and effective vaccine in this younger population is an important step forward in the fight against this pandemic,” Marco Cavaleri, head of health threats and vaccine strategy at the Amsterdam-based EMA, said.
The EU regulator authorized the vaccine for younger adolescents after receiving data from the United States showing it to be highly effective against infection. In a study involving 2,000 adolescents, none of those who received the vaccine got COVID-19, compared with 16 in a control group that received a placebo, Cavaleri said.
“The vaccine was well-tolerated, and the side effects in this age group were very much similar (to) what we’ve seen in young adults and not raising major concern at this point in time,” he said.
The EMA decision needs to be rubber-stamped by the European Commission, and national regulators can decide whether the vaccine will be offered to children under 16 in each country.
The recommendation follows similar decisions by regulators in Canada and the U.S. last month, as rich countries slowly approach their vaccination targets for adults and look to immunize as many people as possible.
|In this Friday, April 23, 2021 file photo, European Commission President Ursula von der Leyen, second left, speaks with Pfizer CEO Albert Bourla, center right, during an official visit to the Pfizer pharmaceutical company in Puurs, Belgium. The European Union cemented its support for Pfizer-BioNTech and its novel COVID-19 vaccine technology on Saturday, May 8, 2021 by agreeing to a massive contract extension for a potential 1.8 billion doses through 2023. (John Thys/Pool via AP, File)|
Researchers will continue to monitor the Pfizer-BioNTech vaccine’s long-term protection and safety in study participants for another two years. Cavaleri acknowledged that rare adverse effects may not have been picked up in the relatively small study on which authorization was based.
“Once the vaccine will be deployed, it will be important to continue monitoring the performance of the vaccine and to determine if there is any safety issue,” he said, adding that recent months had shown Europe’s reporting system is able to detect possible problems in vaccines.
The EMA last month added warnings about the possible risk of rare blood clots in people who had received a dose of vaccines made by AstraZeneca or Johnson & Johnson, after some countries reported a very small number of the millions vaccinated had experienced rare blood clots.
The important of Covid vaccination on children
In the U.S., children represent about 14% of the country’s coronavirus cases and at least 316 have died, according to the American Academy of Pediatrics. Doctors have also identified a rare inflammatory syndrome in a very small proportion of children sickened by COVID-19.
The Food and Drug Administration on Monday approved Pfizer and BioNTech’s request to allow their Covid-19 vaccine to be given to kids ages 12 to 15 on an emergency use basis, allowing states to get middle school students vaccinated before the fall, CNBC reported.
The U.S. agency granting use of the shot in adolescents will also accelerate the nation’s efforts to drive down infections, public health officials and infectious disease experts say.
The two-dose vaccine is already authorized for use in people 16 and older. The Centers for Disease Control and Prevention’s vaccine advisory committee has scheduled a meeting Wednesday to review the shots for kids. If approved by the CDC as expected, it could be distributed to adolescents as soon as this week.
Although COVID-19 in children is usually milder than in adults, some kids can get very sick and have complications or long-lasting symptoms that affect their health and well-being. The virus can cause death in children although this is rarer than for adults.
Like adults, children also can transmit the coronavirus to others if they’re infected, even when no symptoms are present. The COVID-19 vaccine protects against this potential harm to the child and others, including family members and friends who may be susceptible.
Another reason to consider a COVID-19 vaccine for your child is to protect the health of the broader community. Each child or adult infected with the coronavirus provides a chance for the virus to mutate and create a variant that might prove more dangerous or resistant to the available vaccines and therapies. Fewer overall infections among the population means less chance of dangerous coronavirus variants.
Finally, schools sometimes require vaccinations (such as those for diphtheria or whooping cough), and your child’s school might require COVID-19 vaccination for students returning to in-person learning.
Why is the WHO concerned?
Earlier on Friday, the WHO's Hans Kluge warned that the vaccine rollout across Europe was still "too slow".
"The pandemic will be over once we reach 70% minimum coverage in vaccination," he told AFP news agency.
Mr Kluge said he remained concerned about the increased contagiousness of new variants, adding that speed was of the essence, according to BBC.
"We know for example that the B.1617 (Indian variant) is more transmissible than the B.117 (UK or Kent variant), which already was more transmissible than the previous strain," he said.
"Our best friend is speed, the time is working against us. We need to accelerate, we need to enlarge the number of vaccines."
France is to open up vaccinations to everyone aged over 18 from 31 May, the government has said. Until now only adults aged 50 and over have been eligible.
Canada was the first country in the world to authorise the use of the Pfizer vaccine for children between 12 to 15, saying it made the decision based on data from phase three clinical trials.
The US Food and Drug Administration (FDA) followed suit days later, calling it "a significant step in the fight against the Covid-19 pandemic".
Both Moderna and Pfizer-BioNTech have been testing their vaccines in children from ages 6 months to 11; they get a lower dose than what teens and adults receive. China’s Sinovac has also submitted early data to the country’s regulators, hoping to prove its vaccine is safe in children as young as 3.
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