COVID-19 vaccines Archives - Page 7 of 24

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…

Russia’s Sputnik-V vaccine has not yet received EU and WHO backing

Sputnik V in vials. Image from Mos.ru via Wikipedia.

The World Health Organization spokesperson Fadéla Chaib acknowledged undisclosed issues had delayed its emergency use authorization of Russia’s Sputnik V COVID-19 vaccine.

Chaib added that the WHO was working through the issues while Russian Health Minister Mikhail Murashko recently said Russian officials were completing the final paperwork needed for the filing.

Meanwhile, European Union officials have accused Russian officials of delaying inspections required for E.U. authorization of the vaccine.

Russian officials returned the criticism, blaming the European Medicines Agency for delaying authorization of the Sputnik V vaccine.

A recent press release from the Russian News Agency said it had filed paperwork related to mutual recognition of COVID vaccination certificates. The country is also preparing for a visit by EMA officials as pa…

Moderna to build mRNA plant in Africa

As the pendulum of vaccinating the world against COVID-19 begins to swing to developing countries, Moderna (NSDQ:MRNA) will build an mRNA facility in Africa that could produce as many as 500 million 50-µg vaccine doses annually.

Its currently authorized booster has a 100-µg dose of mRNA, but the company aims to use a 50-µg dose for boosters.

Moderna is prepared to invest up to $500 million in building the facility, which would house equipment for drug substance manufacturing and potentially fill/finish and packaging.

The company has not yet selected a site for the facility but said it plans on beginning the selection process soon.

While COVID-19 vaccine production is its initial focus, Moderna’s CEO Stephane Bancel has stressed that the company has grander ambitions. Its pipeline has 20 prophylactic vaccine candidates for a range of viruses. In addition, it has several other investigational therapeutics in development.

In related news, Poli…

AstraZeneca seeks EUA for COVID-19 prophylaxis

AstraZeneca (LON:AZN) has filed paperwork with the FDA for an emergency use authorization (EUA) for AZD7442, a long-acting antibody (LAAB) cocktail, as a COVID-19 prophylaxis.

The paperwork filed for the EUA request includes data from the PROVENT and STORM CHASER Phase 3 trials.

A Phase 3 trial of AZD7442 showed statistically significant protection against COVID-19 infection. Compared to the placebo, the investigational drug offered 77% protection in the PROVENT trial against symptomatic disease compared to placebo.

The PROVENT study included 5,197 participants, with two-thirds receiving AZD7442 and the remainder getting placebo.

A single injection of AZD7442 could offer up to 12 months of protection from symptomatic SARS-CoV-2 infection.

The study also found that the drug was well-tolerated.

AstraZeneca foresees that the drug would be used alongside vaccines to protect vulnerable populations.

AZD7442 comprises two agents, tix…

Sweden and Denmark pause Moderna COVID-19 vaccine for younger age groups

Sweden and Denmark announced they would recommend younger individuals avoid obtaining Moderna’s (NSDQ:MRNA) vaccine until further notice, citing the potential risk of myocarditis and pericarditis.

Sweden recommended halting the use of the vaccine in individuals born in 1991 or later. Meanwhile, the Danish Health Agency advised that the vaccine should not be used in individuals under 18.

MRNA shares dipped 5.10% apiece in mid-day trading.

The Public Health Agency of Sweden concluded that the connection between the Moderna vaccine and heart inflammation was “clear,” “especially after the second dose.” The risk, however, was very rare, it added.

The Swedish agency noted that it was conducting further research to further investigate the risk of myocarditis and pericarditis.

Denmark has resolved to continue vaccinating eligible individuals under 18 with the Pfizer/BioNTech vaccine. Sweden has reached a similar conclusion.

Denmark and Swed…

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…

EU committee backs Pfizer-BioNTech vaccine booster doses

Pfizer (NYSE:PFE) and BioNTech SE (NSDQ: BNTX) have received a positive opinion from the E.U.’s Committee for Medicinal Products for Human Use (CHMP) for the use of a Comirnaty booster dose in individuals at least 18 years of age at least six months after the second dose.

The European Commission (EC) will likely make a formal decision on the matter soon. Backing from EC will clear the way for Pfizer-BioNTech boosters throughout the E.U.’s 27 member nations.

BioNTech and Pfizer have provided data to European authorities regarding the safety and efficacy of a booster dose of Comirnaty, also known as BNT162b2.

In September, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) considered expanding the approval of the Comirnaty vaccine to include a booster dose with similar criteria. That committee, however, recommended narrowing the scope of boosters to patients facing a higher than average risk of exposure or severe outcomes from C…

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…

Why is the vaccination rate in the U.S. stalling?

Image courtesy of Pexels

In a recent press briefing, White House press secretary Jen Psaki touched on the flatlining COVID-19 vaccination rates in the U.S.

Despite a series of vaccine mandates, the daily rate of new COVID-19 vaccinations is the lowest it’s been since mid-January, according to CDC data.

Daily U.S. vaccination rates have returned dipped below 500,000 doses per day, which had been a lower threshold in July.

“We did expect that rates of newly vaccinated would decline over time as they have in other countries with more mature vaccination programs,” Psaki said.

Jen Psaki. Image courtesy of Wikipedia.

There have also been similar declines in vaccination rates in countries with advanced vaccination programs. Examples include the United Kingdom, Israel and Canada. “As a greater percentage of the population is vacci…

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…

Pfizer and BioNTech submit initial data to FDA on its COVID-19 vaccine and younger children

Pfizer (NYSE:PFE) and BioNTech (NSDQ: BNTX) plan to formally seek FDA emergency authorization in the coming weeks for the use of their Comirnaty (BNT162b2) vaccine in children 5 to 11.

The news came today as the companies announced the submission of initial Phase 2/3 trial data to FDA.

The companies last week announced that the vaccine had favorable immunogenicity and tolerability in children 5 to 11.

Vaccine recipients in the clinical trial received a 10-μg dose of mRNA, which is one-third of the amount the company had studied in 16 to 25 year-olds.

Pfizer and BioNTech also plan to submit the data to a peer-reviewed journal.

The companies expect data from younger children as soon as the fourth quarter of the year.

“We are pleased to be able to submit data to regulatory authorities for this group of school-aged children before the start of the winter season,” said Dr. Ugur Sahin, CEO of BioNTech, in a statement. “The safety profile a…