COVID-19 vaccines Archives - Page 6 of 24

China begins administering COVID-19 vaccines to children as young as 3

In China, roughly 80% of the population is vaccinated against COVID-19.

The country, along with Cuba, is also among the first to begin vaccinating young children. At least five out of 23 provinces have started administering shots to children aged three to 11.

China plans on hosting the 2022 Winter Olympics from February 4–20, 2022, in Beijing and the surrounding Hebei.

China is not allowing foreign spectators to attend the event.

The International Olympic Committee is also requiring that athletes, team staff and journalists who travel to Beijing for the Olympics be fully vaccinated or face a 21-day quarantine. In addition, attendees will also undergo mandatory daily PCR testing.

China has authorized vaccines from Sinopharm (HKG:1099) and Sinovac for children as young as three, but, to date, it has only vaccinated children 12 and up until recently.

In the West, the U.S. and several countries in Europe have authorized COVID-19 vaccines…

Moderna releases positive interim Phase 2/3 COVID-19 vaccine data for children 6 to 11

Moderna (NSDQ:MRNA) said two 50-μg doses of its mRNA-1273 vaccine fared well in a planned interim analysis of the Phase 2/3 KidCOVD study involving children between the ages of six and 11.

Last week, rival vaccine maker Pfizer (NYSE:PFE) announced that two 30-μg doses of the BNT162b2 vaccine were 90.7% against COVID-19 in a study involving children aged five to 11.

Moderna did not release interim efficacy numbers. Instead, it announced that two doses of its vaccine led to antibody levels 1.5 times higher in children than those it found in young adults in the Phase 3 COVID-19 study.

Moderna also reported that the shots were generally well-tolerated in the age cohort, which had 4,753 participants.

Side effects were similar to those found in adults, including fatigue, headache, fever, and injection-site pain most frequently.

The company reported that the study met its primary endpoint and that it would submit the data to FDA and other regulato…

Pfizer-BioNTech COVID-19 vaccine was 91% effective in 5- to 11-year-olds in Phase 3 study

Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) have announced that their COVID-19 vaccine was 90.7% effective at protecting against symptomatic COVID-19 in children ages 5 to 11.

The study concluded that a 10-µg dose of the BNT162b2 vaccine, which is one-third the amount authorized for people 12 and older, had the best benefit-risk profile.

Recipients of 20- and 30-µg doses had significantly higher rates of mild or moderate side effects, including fatigue, headache, chills and muscle pain.

The independent Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet next week to discuss the prospect of recommending the vaccine for use in 5- to 11-year-olds to the FDA.

The BNT162b2 vaccine is currently FDA approved for people 16 and older. An emergency use authorization currently covers children aged 12 to 15.

One concern regarding the use of the vaccine in younger children is its association with myocarditis an…

CDC panel unanimously backs J&J and Moderna vaccine boosters

CDC’s Advisory Committee on Immunization Practices (ACIP) has recommended the Janssen (NYSE:JNJ) COVID-19 vaccine booster at least two months after the initial dose.

The committee also recommended a booster of the Moderna’s (NSDQ:MRNA) COVID-19 vaccine for people 65 and a handful of other demographics. Also eligible for boosters are individuals at least 18 who are immunocompromised and those who have frequent occupational or institutional exposure to SARS-CoV-2.

The recommendation for the Moderna boosters pertains to the 50-µg dose level, which is half the level used in the primary series.

CDC Director Dr. Rochelle Walensky will now decide whether to accept or alter the ACIP recommendations. For the Pfizer-BioNTech booster, Walensky opted to support boosters for a larger segment of people than the ACIP had recommended.

Walensky is likely to issue a final decision in the coming days.

The CDC advisors also recommended allowing Americans to ch…

Novartis to continue manufacturing Pfizer/BioNTech vaccine

Novartis (NYSE:NVS) has announced that it has reached an agreement with BioNTech (NSDQ:BNTX) and Pfizer (NYSE:PFE) to produce their popular COVID-19 BNT162b2 vaccine.

The companies reached a new production agreement that will leave Novartis responsible for fill-and-finish operations related to the mRNA-based vaccine from Pfizer and BioNTech.

Under the agreement, Novartis will produce at least 24 million doses of the vaccine in 2022 in its facilities in Ljubljana, Slovenia.

This year, Novartis had an agreement for the fill and finish of more than 50 million doses.

For the agreement pertaining to 2022, Novartis intends to obtain bulk mRNA from BioNTech to fill into vials under sterile conditions. The company will return the vaccine doses to BioNTech for distribution.

In related news, Pfizer recently announced data from a Phase 3 study, which found that a booster dose of its vaccine was 95.6% effective against COVID-19 in a period when the Del…

Why COVID-19 booster criteria will remain complicated for now

The FDA has authorized COVID-19 vaccine boosters for many people who are fully vaccinated.

Individuals seeking boosters must currently navigate a sort of checklist to confirm their eligibility.

The criteria for the Janssen vaccine are the simplest: Anyone who has received a single dose of that vaccine can receive an additional dose two months or more after the first.

The Pfizer-BioNTech and Moderna boosters are available to fully vaccinated people 65 or older, provided six months have elapsed after receipt of the last dose. In addition, individuals 18 and older who live in a long-term care facility are also eligible. Those who live or work in high-risk settings also can get the shot, as can individuals with certain medical conditions.

When asked when FDA would authorize boosters to all individuals 18 and older, Dr. Peter Marks, a senior official at FDA, said in a media briefing, “I think we may get…

White House reveals plan to vaccinate children aged 5 to 11

Photo by Aaron Kittredge from Pexels

The White House says that vaccination will be readily available and free of charge for children between the ages of five and 11, assuming the FDA and CDC authorize them.

The authorization of a vaccine for that age group would make 28 million additional Americans eligible for vaccination.

Pfizer recently asked FDA to extend emergency use authorization (EUA) to its vaccine, which it jointly developed with BioNTech.

An FDA advisory committee will convene on October 26 to discuss Pfizer’s request to amend the EUA. While some members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) have signaled concern about the risk of myocarditis linked to mRNA vaccines in children in the past, clinical trial data suggest the vaccines are safe and effective in five- to eleven-year-olds.

The White House said it would begin dispensing shots with…

FDA to authorize heterologous vaccination

Media reports suggest FDA will soon permit so-called “mix-and-match” COVID-19 boosters as it prepares to authorize boosters from Moderna (NSDQ:MRNA) and Janssen (NYSE:JNJ).

The move would give healthcare workers more leeway in administering boosters, as The New York Times reported.

During last week’s Vaccines and Related Biological Products Advisory Committee (VRPAC) meeting, preliminary results from a federally-funded study suggested that heterologous boosters were non-inferior to homologous boosters. “The heterologous [recipients] had as good or higher neutralizing antibodies following at day 15,” said Dr. Kristen Lyke, a clinical translational investigator affiliated with the University of Maryland, who spoke during the VRBPAC meeting.

Although the research Lyke referenced was not powered to make definitive comparisons between various heterologous vaccine booster regimens, mRNA vaccines appeared to be more efficacious when used as boosters and overall…

The European Union has become a leading COVID-19 vaccine exporter

The European Union is now one of the largest exporters of COVID-19 vaccines globally, having provided 150 nations with more than one billion vaccine doses.

The U.S. has exported fewer than 200 million vaccine doses to date but has pledged to donate more than one billion.

China has pledged to donate two billion doses by the end of the year. As of September 23, the Chinese foreign ministry stated that China had exported 1.2 billion doses to more than 100 countries.

The EU announced in September that it would provide an additional 200 million doses to low-income countries in Africa and elsewhere.

“We know that other countries also have to step up,” EU Commission President Ursala von der Leyen told the AP. “That’s the only way to beat the pandemic.”

To date, 47.6% of the world’s population has received at least one dose of vaccine, according to Our World in Data. But most of those doses have gone to middle- and high-income nations. Less than 3.…

FDA hits pause on reviewing Moderna COVID-19 vaccine for adolescents

The FDA has decided to postpone deciding whether to extend emergency use authorization of Moderna’s (NSDQ:MRNA) COVID-19 vaccine.

Some regulators have concluded that the risk of myocarditis is higher in recipients of the Moderna vaccine than the Pfizer-BioNTech vaccine.

Japan recently authorized men 30 and under who received an initial dose of the Moderna vaccine to receive a second dose of the Pfizer-BioNTech vaccine. Japanese authorities also recommended requiring a four-week interval between the first and second doses in this subpopulation — the same as the 28-day interval Moderna recommended for the second dose.

Sweden, Denmark, Norway and Finland recently recommended that younger age groups avoid obtaining the Moderna COVID-19 vaccine until further notice.

Health authorities in Europe are scrutinizing data to determine whether the Moderna vaccine increases the risk of myocarditis in younger recipients.

FDA data concerning the Moderna a…

VRBPAC recommends expanding EUAs to authorize Janssen and Moderna boosters

Image from Sam Moqadam on Unsplash

The U.S. appears to be on the verge of expanding the use of COVID-19 vaccine boosters after an advisory committee backed boosters for the Johnson & Johnson (NYSE:JNJ) and Moderna (NSDQ:MRNA) vaccines.

On October 14 and 15, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) separately voted 19–0 to recommend boosters of both products for high-risk populations.

The committee’s guidance for the two-dose mRNA vaccines from Moderna and Pfizer-BioNTech (NYSE: PFE/NSDQ:MRNA) was to allow boosters six months after completion of a primary series.

Conversely, VRBPAC recommended that recipients of the single-dose Janssen vaccine receive a booster at least two months after the initial dose.

Several panelists balked at the word “booster” in reference to the Janssen vaccine, arguing that would be more accurate to refer to it as a two-dose va…

Bayer abandons plans to produce first-generation CureVac vaccine

Bayer (ETR:BAYN) had planned to retool a facility in Wuppertal, Germany, to produce CureVac’s (NSDQ:CVAC) COVID-19 vaccine. But Leverkusen, Germany–headquartered Bayer has put those plans on ice, according to the German paper Leverkusener Anzeiger.

Bayer had planned on producing 160 million doses of the vaccine annually.

In June, CureVac reported that its COVID-19 vaccine was 48% efficacious in an international Phase 2b/3 study focused on various age groups. Despite having lower efficacy than the mRNA vaccines from rivals Moderna and Pfizer/BioNTech, CureVac had assumed in July that it would receive marketing authorization to distribute the vaccine in Europe.

The company announced it would withdraw its first-generation vaccine candidate, CVnCoV, from regulatory review at the European Medicines Agency. CureVac also canceled an existing advanced purchase agreement with the European Commission related to the CVnCoV vaccine.

Earlier this week, CureVac…