COVID-19 vaccine trial Archives - Page 2 of 13

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…

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 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…

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…

FDA advisory panel unanimously backs Moderna boosters

All 19 members of the Vaccines and Related Biological Products Advisory Committee voted to expand emergency use authorization of the Moderna COVID-19 vaccine to include boosters.

The recommendation, however, limited its use to three main groups, including those 65 and older and individuals 18 to 64 with an elevated risk of developing severe COVID-19. In addition, the recommendation extended to individuals with a high risk of exposure to the virus in occupational or institutional settings that could lead to severe complications from COVID-19.

The conclusions mirrored the FDA’s current recommendations for the Pfizer-BioNTech vaccine, a similar vaccine that uses a lower dose of mRNA.

Regarding the dose level, Moderna requested a 50 microgram dose for the boosters, which is half the dose of the primary series of the same vaccine.

While the committee members supported the booster, several members had reservations about its potential use in popula…

Johnson & Johnson to ask FDA to authorize COVID-19 booster

Johnson & Johnson’s Janssen division (NYSE:JNJ) is planning on requesting expanding the emergency use authorization (EUA) for its Ad26.COV2.S COVID-19 vaccine to include boosters.

The previous EUA covered a single dose of the vaccine.

Despite its initial advantage as a single-dose vaccine, Ad26.COV2.S has failed to match the popularity of the mRNA vaccines from Pfizer and Moderna.

Authorities in the U.S. and EU have linked the vaccine to extremely rare blood clotting episodes. And recently, officials at the European Medicines Agency found another possible link between the vaccine and clotting in deep veins in Ad26.COV2.S recipients, Reuters reported.

A recent CDC study found that a single dose of the Janssen vaccine was 71% effective in preventing hospitalization from COVID-19. By contrast, the two-dose Moderna and Pfizer-BioNTech vaccines were 93% and 88% effective, respectively.

Janssen said an additional dose of Ad26.COV2.S vaccine b…

India’s Gennova developing mRNA COVID-19 vaccine

India is vying to create domestic mRNA COVID-19 vaccines, with Gennova Bio (Maharashtra) emerging as a frontrunner. The company’s investigational HGCO19 vaccine will be the focus of a Phase 2/3 study.

The vaccine, developed in collaboration with privately-held Seattle-based HDT Bio, has received funding from India’s Department of Biotechnology and Ministry of Science and Technology.

Lyophilized (freeze-dried) HGCO19 has less stringent storage requirements than the vaccines from Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA), making it a better fit for developing nations.

Gennova’s experimental vaccine is also unique in that it uses self-amplifying mRNA in place of the non-replicating mRNA found in vaccines from Pfizer and Moderna.

Gennova aims to win emergency use authorization for the vaccine candidate in India by the end of the year.

India has also approved a DNA-based vaccine from Zydus Cadila (NSE:CADILAHC) known as ZyCoV-D.

mRNA quic…

FDA could support 50-µg booster dose of Moderna vaccine

The FDA could authorize the use of Moderna (NSDQ:MRNA) COVID-19 vaccine boosters at a half-dose level, according to a report from Bloomberg.

Each primary series dose of the Moderna vaccine contains 100 µg of mRNA. By contrast, the Pfizer-BioNTech vaccine uses a 30-µg dose level for the primary series and boosters.

Earlier this month, Moderna CEO Stéphane Bancel said that recent data from its Phase 3 COVD study “supports the need for a booster to maintain high levels of protection.”

E.U. authorities are also reviewing data related to booster doses of the Moderna vaccine.

In addition, the European Medicines Agency is considering authorizing a booster dose of the Pfizer-BioNTech vaccine. The agency said it hopes to announce its decision in early October.

NIAID Director Dr. Anthony Fauci ultimately predicts that regulatory authorities will view mRNA vaccines as requiring three doses.

While U.S. authorities now recommend matching boosters…

CDC analysis finds COVID-19 boosters generally elicit mild-to-moderate side effects

Most third doses of mRNA COVID-19 vaccines elicit side effects in line with that of the second dose, according to a CDC report.

The study analyzed immunocompromised recipients of the Pfizer-BioNTech and Moderna COVID-19 vaccine recipients eligible for a third dose.

It pulled data from 22,191 V-safe registrations. V-safe is a CDC-created smartphone-based system for tracking adverse events. Just under one-third (31.8%) of participants reported health impacts, while 28.3% said they could not perform routine daily activities — most often on the day following receipt of the third dose.

Referencing the report at a White House briefing, CDC Director Dr. Rochelle Walensky, concluded “COVID-19 vaccine booster doses so far are well tolerated”

Injection site reactions were slightly more common among the mRNA vaccine recipients than after receiving the second dose. Systemic reactions were somewhat less common post-third dose for both Pfizer-BioNTe…

Moderna CEO predicts the pandemic will be over in a year

In an interview with the German-language Neue Zürcher Zeitung, Moderna leader Stéphane Bancel shared his predictions about the course of the pandemic.

When asked when the pandemic phase would end, Bancel replied: “As of today, I assume in one year.”

Seniors will need yearly COVID-19 boosters, Bancel said, while the rest of the public will benefit from boosters once every three years.

The durability of COVID-19 vaccines depends on age. Bancel pointed to the coronavirus OC43 as a case in point. The virus, which causes mild-to-moderate respiratory infections, tends to infect older people annually, while younger people about once every three years. “That shows us approximately the path we will tread with COVID-19,” Bancel told the newspaper.

The company is developing a flu vaccine that will cover OC43. In addition, the company is also developing a combination flu–COVID-19 vaccine.

Bancel is confident in the need for boosters, arguing that the e…