US To Weigh Authorizing Pfizer COVID-19 Vaccine For Younger Children

The Pfizer Covid-19 vaccine is prepared for administration at a vaccination clinic. Frederic J. BROWN / AFP

 

A high-level medical panel of US government advisors will meet Tuesday to decide whether to authorize the Pfizer Covid-19 vaccine for children aged five to 11 years old.

If, as is widely expected, the independent experts convened by the Food and Drug Administration (FDA) vote in favor, an emergency authorization could follow within weeks.

This would make 28 million younger children eligible for the shots in November.

The question before the panel: based on the scientific evidence available, do the benefits of the two-dose vaccine, given three weeks apart, outweigh the known risks?

Ahead of the meeting, the FDA uploaded an analysis by Pfizer that showed the vaccine — given at 10 micrograms instead of 30 micrograms as in older groups — was 90.7 percent effective at preventing symptomatic Covid-19, and there were no serious safety issues.

The FDA also posted its own briefing document containing a risk-benefit analysis, which indicated the agency’s scientists believe the benefits exceed the most worrying potential side-effect for this age group: myocarditis, or heart inflammation.

“My initial thought is that the benefits of vaccinating children five through 11 years outweigh the risks of myocarditis and other safety concerns that people may have,” Henry Bernstein, a pediatrician at Cohen Children’s Medical Center in New York, told AFP.

Overall, 160 children aged five to 11 have died from Covid-19 in the United States since the start of the pandemic, according to official data — a tiny fraction of the total of more than 730,000.

But millions have been infected and thousands hospitalized. There have also been more than 5,000 cases of multisystem inflammatory syndrome in children (MIS-C), a rare but highly serious post-viral complication, which has claimed 46 lives.

“Of course, (we) want to protect the children, but we also want them to not be transmitting SARS-CoV-2 virus to family members and other people in the community,” said Bernstein.

– Myocarditis rate likely low –

Pfizer evaluated safety data from a total of 3,000 vaccinated participants, with the most common side-effects mild or moderate, including injection site pain, fatigue, headache, muscle pain and chills.

There were no cases of myocarditis or pericarditis (inflammation around the heart), but the company said there were not enough study volunteers to be able to detect highly rare side-effects.

Very rare instances of myocarditis were only detected in adolescents after the vaccine was authorized in June and given to millions of people in that age group, rather than the thousands that were tested in trials.

Scientists believe it will be even rarer among younger children, but don’t expect to know just how rare until it is green-lighted.

The FDA acknowledged that, hypothetically speaking, if Covid-19 transmission was crushed within communities — as was the case last in June 2021 — the number of vaccine-induced myocarditis cases could exceed the number of Covid-19 hospitalizations prevented.

But even then, it added, the benefits might still exceed the risks, because non-hospitalized Covid-19 cases can have more serious consequences than side-effects, which are normally temporary.

The United States is emerging from its latest wave driven by the Delta variant.

But cases remain high in northern states such as Alaska, Montana, Wyoming and Idaho, which are experiencing colder weather and have lagging vaccination rates.

Overall, 57 percent of the total population is now fully vaccinated.

Vaccine confidence has risen in recent months, but the United States remains behind every other G7 nation in percent of population fully vaccinated.

NLC Asks Workers To Take COVID-19 Vaccine For ‘A Chance To Stay Alive’

 

The President of the Nigerian Labour Congress (NLC), Ayuba Wabba on Monday asked workers across the country to take the COVID-19 vaccine for a chance to stay alive.

Speaking during a press conference in Abuja, Wabba appealed to workers to take advantage of vaccination provisions made by the Federal Government, in order to reduce hospitalisations and fatalities among workers.

According to him, while health issues need to be approached with great caution, it would be foolhardy to undermine the protective powers of vaccines against the virus.

“The truth is that despite being imperfect, the COVID-19 vaccine has given all of us a better chance of fighting the virus and staying alive,” he said.

READ ALSO: Those Claiming Anambra Election Won’t Hold Are Lying, Says Ezeife

“The COVID-19 pandemic has brought some of the biggest strains, stress and squeeze to the workplace. Thousands of workers have already died. In fact, just last week, the World Health Organisation posited that as of the third week of October, we have lost about 180,000 frontline health workers.

NLC President, Auyuba Wabba speaks during a press conference in Abuja on October 25, 2-21.

 

“I understand some people prefer to view COVID-19 vaccination with caution. Yes, it is important to proceed on issues of public health with great caution. Yet, it would be foolhardy to elevate caution above scientific evidence and facts from public health records.

“I urge workers all over the world to take advantage of the COVID-19 vaccines and keep themselves, their families and their colleagues at work safe and free from the morbid threats of the corona pandemic.”

The NLC President’s appeal follows the recent directive of the Federal Government that civil servants who refuse to be vaccinated will need to show test results, confirming that they are negative before they can access public offices, beginning from December 1.

 

Moderna Reports Positive Results For COVID-19 Vaccine In Younger Children

(FILES): This creative image taken in a studio in Paris on November 16, 2020, showing a syringe and a vaccine vial with the reproduced logo of a US biotech firm Moderna, (Photo by JOEL SAGET / AFP)

 

US biotech firm Moderna said Monday its Covid vaccine was safe and produced a strong immune response in children aged 6-11, adding it would submit trial data to global regulators soon.

The news comes as a panel of government advisors was preparing to meet Tuesday on the question of whether to authorize the Pfizer vaccine in kids aged 5-11, with top infectious disease expert Anthony Fauci predicting it would be available by mid-November.

“We are encouraged by the immunogenicity and safety profile of mRNA-1273 in children aged 6 to under 12 years and are pleased that the study met its primary immunogenicity endpoints,” Moderna chief executive Stephane Bancel said in a statement.

An interim analysis from a mid-to-late stage clinical trial of 4,753 children showed that two doses of vaccine produced a high level of neutralizing antibodies — Y-shaped proteins that bind to the coronavirus and block it from entering human cells.

The vaccine was dosed at 50 micrograms, which is half of what is used among adults, but still produced on average 1.5 times as many antibodies in children as it did in young adults given the higher dose.

The majority of adverse events were mild or moderate, including fatigue, headache, fever, and injection site pain.

These early results, released via a press statement, do not yet include a vaccine efficacy estimate, which may be expected at a later time once cases have accrued.

– FDA meeting on Pfizer –

The Moderna news comes as the US Food and Drug Administration (FDA) is preparing to convene a panel of advisors to vote on whether to greenlight the Pfizer shot for younger children, paving the way for 28 million more Americans to be vaccinated.

A briefing document posted on the FDA’s website indicated the agency believes benefits outweigh the most worrying side effect for this age group, namely myocarditis, or heart inflammation.

“The overall analysis predicted that the numbers of clinically significant Covid-19-related outcomes prevented would clearly outweigh the numbers of vaccine-associated excess myocarditis cases,” the document said.

But it acknowledged the benefit-risk calculus would differ when community transmission is very low, as was the case in the United States in June 2021.

The FDA also uploaded Pfizer’s efficacy analysis, with the company estimating a two-dose course of its vaccine at 10 micrograms was more than 90 percent effective in preventing symptomatic disease.

Overall, more than 150 children aged 5 to 11 have died from Covid in the United States since the start of the pandemic, according to official data.

“If all goes well, and we get the regulatory approval and the recommendation from the CDC, it’s entirely possible, if not very likely, that vaccines will be available for children from 5 to 11 within the first week or two of November,” Fauci told ABC News Sunday.

U.S. To Allow Vaccine Booster ‘Mix And Match’

The Pfizer Covid-19 vaccine is prepared for administration at a vaccination clinic. Frederic J. BROWN / AFP

 

The US Food and Drug Administration (FDA) is preparing to allow “mix and match” coronavirus vaccine boosting, in which people get a different additional shot to the dose they initially received, US media reported.

Citing sources familiar with the situation, the New York Times said the FDA might make the announcement on Wednesday when it is also expected to authorize boosters for the Moderna and Johnson & Johnson vaccines.

A preliminary study released in the United States last week showed that people who have received the J&J vaccine may benefit from a booster dose of a different, messenger-RNA vaccine such as Pfizer or Moderna.

But multiple reports quoted people familiar with the discussions as saying one shot may not be recommended over another, and the FDA could say using the same vaccine is preferable when possible.

“People should generally get the same vaccine as their initial series,” a federal official told the Washington Post.

Proponents of mixing and matching point to its benefits in terms of simplifying vaccine rollout, and ensuring those who need boosters can get them regardless of which jab they initially had.

“From a public health perspective, there’s a clear need in some situations for individuals to receive a different vaccine,” Amanda Cohn, a high-ranking Centers for Disease Control and Prevention official, told the New York Times.

In July the World Health Organization’s chief scientist Soumya Swaminathan said mixing and matching vaccines was “a bit of a data-free, evidence-free zone.”

The US study on boosters, which has not yet been peer-reviewed, has several limitations.

The number of participants was small, and the immune response could evolve beyond the 15 days observed during the study.

In the United States, over-65s, adults with high-risk medical conditions, and those in jobs where they are frequently exposed to the virus are eligible to receive booster shots.

The World Health Organization’s vaccine advisers recommended last week that people with weakened immune systems should be offered an additional dose of all WHO-approved Covid-19 vaccines.

But the WHO wants a moratorium on booster doses for the general population until the end of the year to prioritize first doses in the dozens of nations starved of vaccines.

Defiant Brazilian President Makes U-Turn, Set For COVID-19 Vaccination

File Photo of Brazilian President Jair Bolsonaro. AFP

 

Brazilian President Jair Bolsonaro has confirmed he will not get vaccinated against Covid-19, having previously said he would be the “last Brazilian” to do so.

The far-right leader has generated controversy over his handling of the coronavirus pandemic and for initially downplaying the seriousness of the virus, despite catching it himself.

“I’ve decided not to get vaccinated. I’m looking at new studies, I already have the highest immunization, why would I get vaccinated?” the 66-year-old said late Tuesday night in an interview with Jovem Pan radio.

“It would be the same as betting 10 reais on the lottery to win two. It doesn’t make sense.”

A coronavirus skeptic, Bolsonaro previously claimed the Pfizer vaccine could turn people into crocodiles due to secondary effects.

Since contracting Covid-19 in July 2020, Bolsonaro has repeatedly claimed that tests have shown he has a large number of antibodies to fight the virus and thus does not need to be vaccinated, something experts dispute.

Bolsonaro is also strongly opposed to the health passes, given to those that are vaccinated, required by some large Brazilian cities in order to access certain public spaces.

“For me, freedom comes before everything else. If a citizen doesn’t want to get vaccinated, that’s his right and that’s the end of it,” Bolsonaro told Jovem Pan.

Almost 100 million of Brazil’s 213 million population are entirely vaccinated against Covid-19, while another 50 million have had one dose.

Last week, the country surpassed 600,000 deaths from Covid-19, the second-worst death toll in the world after the United States.

Bolsonaro’s refusal to get vaccinated has also solicited criticism from abroad, notably in September when he traveled to New York for the UN General Assembly.

While there, he was photographed standing in a street eating pizza, something Brazilian press attributed to his being unable to enter restaurants due to being unvaccinated.

AFP

Algeria Begins Sinovac Covid-19 Vaccine Production

 

Algeria on Wednesday started producing the Covid-19 vaccine developed by Chinese firm Sinovac, with production expected to be eight million doses a month.

Prime Minister Aimene Benabderrahmane, who attended the launch of the production process at a factory in the eastern city of Constantine, called it a “big achievement”.

Production could be doubled in the North African nation if needed, officials said.

“Algeria aims to achieve other projects of this kind,” Benabderrahmane said, praising the country’s pharmaceutical industry.

Lotfi Djamel Benbahmed, Algeria’s minister for the pharmaceutical industry, has said the country plans to export the vaccines.

He said Saidal, the firm making the jabs, was so far the only African company to be licensed to produce the jab.

Following a sharp spike in Covid-19 cases in past months, Algeria has seen a drop in recent weeks.

Algeria, the biggest African nation by size, announced this month a campaign to vaccinate some 70 percent of its 44 million population by the end of the year.

AFP

India To Export Eight Million COVID-19 Jabs In October

A health worker prepares to inoculate a person with a dose of the Covishield vaccine against the Covid-19 coronavirus at a civil hospital in Amritsar on September 17, 2021.
Narinder NANU / AFP

 

India will export eight million coronavirus vaccine jabs by the end of October after ending its ban on sending doses abroad, a top foreign ministry official said Saturday.

Prime Minister Narendra Modi promised to resume exports at a meeting of leaders from the so-called Quad in Washington as India, Japan, Australia, and the US try to counter growing Chinese influence across the Asia-Pacific region.

Foreign secretary Harsh Vardhan Shringla told reporters on Saturday that most of the eight million doses of the Johnson & Johnson single-shot vaccine will be sent to Asia-Pacific countries.

“This would be ready by the end of October. This is an immediate delivery, from the Quad into the Indo-Pacific region,” Shringla told reporters.

India is one of the world’s biggest vaccine producers and had pledged earlier this year to export one billion Covid-19 jabs by December 2022.

But New Delhi halted exports in May after a devastating coronavirus wave ravaged the country.

India lifted its vaccine export ban this week with new Covid-19 infections and deaths slowing down.

The country suffered weeks of vaccine shortages as a coronavirus surge between March and May killed at least 250,000 and infected tens of millions of people.

It has now administered nearly 840 million vaccine doses. Nearly half of the adult population has had at least one jab and with 16 percent receiving a second dose.

AFP

Johnson & Johnson Announces Positive COVID-19 Booster Data

(FILE) Bottles of the single-dose Johnson & Johnson Janssen COVID-19 vaccine await transfer into syringes for administering on April 23, 2021. JORGE GUERRERO / AFP

 

The Johnson & Johnson COVID vaccine is more effective when given as a two-dose regime, according to new data released by the company on Tuesday.

A second shot is given 56 days after the first provided 75 per cent protection against symptomatic Covid in a global clinical trial, with that level rising to 94 per cent in the United States.

The reason behind this difference was not clear from the company’s press release, but it could be linked to fewer variants in the US when the data accrued.

It was 94 percent effective in preventing severe or critical Covid at least 14 days post final vaccination in America — but there were relatively few cases to judge from.

When a second shot was given two months after the first, antibody levels rose to four to six times higher than observed after the single dose.

Overall, the data is positive news for the almost 15 million Americans who received one dose of the J&J vaccine but have been left in the dark about if and when they might need a booster.

President Joe Biden’s administration in August announced plans for Americans vaccinated with mRNA vaccines (Pfizer and Moderna) to get third shots.

An expert panel convened by the Food and Drug Administration last week greenlighted Pfizer boosters for the elderly, high-risk, and those in high-risk occupations, and decisions on Moderna are expected to follow.

The Centers for Disease Control and Prevention (CDC) has said it expects a second dose of the J&J vaccine will be required, but that it needs more data before making a firm recommendation.

J&J’s new announcement might help inform that strategy. The company said it had provided data to the FDA and other regulatory agencies.

It also said that when a booster was given six months after the first shot, “antibody levels increased nine-fold one week after the booster and continued to climb to 12-fold higher four weeks after the booster,” irrespective of age.

In a separate study of 390,000 US people who received the J&J vaccine from March to July 2021, the efficacy of a single J&J shot was 79 per cent against infection and 81 per cent against hospitalisation.

The estimates for efficacy against hospitalization were higher than those found in two recent studies by the CDC, one of which estimated 68 per cent while the other estimated it was 60 per cent.

AFP

EU Commissioner Hopeful People Vaccinated With AstraZeneca Can Enter US

European commissioner for internal market Thierry Breton gives a press conference about the new European Health Emergency preparedness and response authority (Hera), in Brussels, on September 16, 2021. (Photo by François WALSCHAERTS / AFP)

 

While Washington has not authorised the AstraZeneca vaccine against Covid-19, a European commissioner on Monday expressed hope that travellers from the continent inoculated with the jab will soon be able to enter the United States.

The US government on Monday announced that starting November 1, it will lift the pandemic travel ban on all air passengers who are fully vaccinated and undergo testing and contact tracing.

The unprecedented travel restrictions had raised tensions between the United States and its European allies and had kept relatives, friends and business travelers around the world separated for many months as the pandemic grinds on.

In an interview in Washington with AFP, Thierry Breton, European commissioner for internal market, said the new order covers people vaccinated with jabs recognized by the US Food and Drug Administration (FDA).

The agency has not approved the AstraZeneca shot used by many European nations, however, Breton said he spoke with White House pandemic response coordinator Jeff Zients who “sounded positive and optimistic.”

However, Zients told him that “for the other vaccines, for AstraZeneca in particular, their health agency would decide.”

Whether a decision would come by November 1 when travel resumes, Zients “seemed positive on the dates, too,” said Breton, who coordinates the EU’s supply of Covid-19 vaccines.

Breton said the restrictions “no longer made any sense.”

Despite Europe’s relatively high vaccination rates “we are on the same restrictions as China, Iran, and other countries. It makes no sense at all,” he said.

The United States first imposed the restrictions as the pandemic began in March 2020 on travelers from the European Union, United Kingdom, and China, later extending it to India and Brazil.

However, the availability of Covid-19 vaccines has made continuing the travel ban a point of transatlantic tension.

That worsened in recent days after Australia’s sudden announcement that it will acquire US-built nuclear submarines as part of a new defense alliance, ditching a contract with France for conventionally powered submarines.

AFP

Vaccine Bookings Spike After Italy Extends COVID-19 Pass

FIle Photo: NARINDER NANU / AFP

 

Bookings for coronavirus vaccines in Italy spiked this week after the government said all employees must show proof of a jab, negative test or recent recovery from Covid-19, authorities said.

“On a national level, there was a generalised increase in bookings for the first dose of between 20 and 40 percent compared to last week,” coronavirus commissioner Francesco Figliuolo said in a statement late Saturday.

Reservations for the first dose of the vaccine on Saturday were up 35 percent on the same time a week earlier, he added, without giving the actual figure.

Almost 41 million people in Italy have so far been fully vaccinated, government data shows — close to 76 percent of the population over the age of 12.

But authorities remain concerned about the hold-outs ahead of the winter flu season, and this week extended the so-called “Green Pass” to all public and private workplaces.

Introduced in August initially for indoor restaurant dining, museums and sports events, the pass shows proof of vaccination, a recent negative Covid-19 test or recent recovery from the virus.

This week, Prime Minister Mario Draghi’s national unity government agreed to extend it to all workplaces from October 15, with employees who refuse to comply considered to be absent without pay.

Those exempt from the vaccine for health reasons will be given free coronavirus tests.

Italy was the first European country to face the full force of the pandemic in February 2020 and has the worst recorded death toll in the European Union, at more than 130,000.

The economy was plunged into a deep recession caused by lockdowns last year but with case numbers largely under control since the spring, growth is forecast to jump this year, aided by a huge injection of EU recovery funds.

AFP

EU To Donate 200 Million More Vaccine Doses To Low-Income Countries

A logo for the European Union

 

The European Union is to donate another 200 million Covid-19 vaccine doses to low-income countries, more than doubling its present pledge, the bloc’s chief said on Wednesday.

The extra doses announced by European Commission President Ursula Von Der Leyen come on top of 250 million shots the EU has already promised to give to other countries, particularly ones in Africa.

“I can announce today that the commission will add a new donation of another 200 million doses until the middle of next year,” she told the European Parliament in her annual State of the European Union address.

Von der Leyen told the Strasbourg assembly the donation is “an investment in solidarity, and it is an investment also in global health”.

She recognised the disparity that has emerged between economically advanced countries such as the United States and those in Europe, which have pushed ahead in vaccinating the majority of their populations against the coronavirus, and poorer nations that are struggling to get hold of supplies.

“With less than one percent of global doses administered in low-income countries, the scale of injustice and the level of urgency is obvious,” she said.

Von der Leyen hailed the Europe Union’s vaccination roll-out, which has seen more than 70 percent of its adult population fully inoculated.

She said Europe had done more than any other region to get vaccine doses to other countries, noting that half of the 1.4 billion vaccines produced on its territory had been exported abroad.

AFP

Egypt Plans To Make One Billion Doses Of Sinovac Vaccine In A Year

Laboratory workers fill boxes with vials of China’s Sinovac vaccine against the coronavirus, produced by the Egyptian company VACSERA, in the capital Cairo, on September 1, 2021. PHOTO: Khaled DESOUKI / AFP

 

Egypt said Wednesday it plans to manufacture one billion doses a year of China’s Sinovac vaccine, claiming it would become the Middle East and Africa’s “biggest vaccine producer”.

Under the deal with the Chinese pharmaceutical company, a factory in Cairo will produce more than 200 million doses per year to cover “national needs”, Health Minister Hala Zayed told a press conference.

A second factory will produce three million doses per day, “or around a billion a year”, with a view to exporting the vaccine for Covid-19 and responding to demand in Africa, Zayed added.

READ ALSO: South Africa Scientists Monitoring New COVID-19 Variant

The move would make Egypt “the biggest vaccine producer in the Middle East and Africa”, an official statement said.

Heba Wali, the doctor in charge of the project, said the Egyptian drug authority had given its go-ahead and that “one million doses have already been distributed in Egypt”.

Chinese experts had previously travelled to Egypt to inspect equipment and materials for producing the Sinovac vaccine at factories belonging to state firm Vacsera.

Egypt, with a population of over 100 million, has officially recorded more than 288,000 Covid-19 cases, including over 16,700 deaths.

Some 7.5 million Egyptians have had at least one vaccine dose.

AFP