Tag: fda

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US FDA limits use of J&J Covid vax over blood clot risk

The Johnson & Johnson Covid-19 vaccine was authorized for emergency use in the US on February 27, 2021….reports Asian Lite News

The Food and Drug Administration (FDA) announced that it has limited the authorised use of the Johnson & Johnson Covid-19 vaccine, Janssen, to individuals 18 years of age and older who cannot or will not get other jabs, over the risk of rare blood clots.

“After conducting an updated analysis, evaluation and investigation of reported cases, the FDA has determined that the risk of thrombosis with thrombocytopenia syndrome (TTS), a syndrome of rare and potentially life-threatening blood clots in combination with low levels of blood platelets with onset of symptoms approximately one to two weeks following administration of the Janssen Covid-19 vaccine, warrants limiting the authorised use of the vaccine,” the FDA said in a statement on Thursday.

“Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals,” Xinhua news agency quoted Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research, as saying.

He said the FDA has been closely monitoring the Janssen vaccine and occurrence of TTS following its administration and has used updated information from its safety surveillance systems to revise the authorisation.

The Johnson & Johnson Covid-19 vaccine was authorized for emergency use in the US on February 27, 2021.

Through March 18 this year, the FDA and the Centers for Disease Control and Prevention have identified 60 confirmed TTS cases, including nine fatal cases.

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Health USA

New eye drops could replace reading glasses for millions

According to reports, the new medicine takes effect in about 15 minutes, with one drop on each eye providing sharper vision for six to 10 hours, reports Asian Lite News

A newly-approved eye drop could change the lives of millions of Americans with age-related blurred near vision, a condition affecting mostly people 40 and older, CBS News reported.

Vuity, which was approved by the Food and Drug Administration (FDA) in October, would potentially replace reading glasses for some of the 128 million Americans who have trouble seeing close-up.

The new medicine takes effect in about 15 minutes, with one drop on each eye providing sharper vision for six to 10 hours, according to the company, the CBS News report said.

Toni Wright, one of the 750 participants in a clinical trial to test the drug, said she liked what she saw.

“It’s definitely a life changer,” she told CBS News.

Before the trial, the only way Wright could see things clearly was by keeping reading glasses everywhere — in her office, bathroom, kitchen and car.

“I was in denial because to me that was a sign of growing older, you know, needing to wear glasses,” she said.

It was in 2019 that her doctor told her about a new eye drop with the potential to correct her vision problems, temporarily. The 54-year-old online retail consultant, who works from her farm in western Pennsylvania, instantly noticed a difference, the report said.

“I would not need my readers as much, especially on the computer, where I would always need to have them on,” she said.

Vuity is the first FDA-approved eye drop to treat age-related blurry near vision, also known as presbyopia. The prescription drug utilizes the eye’s natural ability to reduce its pupil size, said George Waring, the principal investigator for the trial.

“Reducing the pupil size expands the depth of field or the depth of focus, and that allows you to focus at different ranges naturally,” he said.

A 30-day supply of the drug will cost about $80 and works best in people 40 to 55 years old, a Vuity spokesperson said. Side effects detected in the three-month trial included headaches and red eyes, the company said.

“This is something that we anticipate will be well tolerated long term, but this will be evaluated and studied in a formal capacity,” the CBS News report quoted Waring as saying.

Vuity is by no means a cure-all, and the maker does caution against using the drops when driving at night or performing activities in low-light conditions.

The drops are for mild to intermediate cases and are less effective after age 65, as eyes age.

Users may also have temporary difficulty in adjusting focus between objects near and far.

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Nod for world’s first oral pill against Covid

Meanwhile, the drug’s emergency authorisation is pending both with the US Food and Drug Administration (FDA) and the European Medicines Agency…reports Asian Lite News.

The UK’s medicines regulator on Thursday approved Merck’s molnupiravir — the world’s first oral antiviral medicine against Covid-19, which can halve the risk of hospitalisation or death for patients with mild or moderate cases of the infectious disease, the company said.

The UK became the first country in the world to approve molnupiravir, which is co-developed with Ridgeback Biotherapeutics, Merck said in a statement.

The pill is administered orally and works by inhibiting the replication of the coronavirus inside the body.

“As an oral therapeutic, molnupiravir offers an important addition to the vaccines and medicines deployed so far to counter the Covid-19 pandemic,” said Merck Research Laboratories Executive Vice President, and President Dr Dean Y. Li, in the statement.

In the UK, molnupiravir will be marketed as LAGEVRIO, the company said.

The UK’s Medicines and Healthcare products Regulatory Agency said the decision “follows a rigorous review of its safety, quality and effectiveness” and made it the “first oral antiviral for the treatment of Covid-19 to be approved”, the CNBC reported.

Meanwhile, the drug’s emergency authorisation is pending both with the US Food and Drug Administration (FDA) and the European Medicines Agency.

Merck is working “to bring molnupiravir to patients around the world as quickly as possible,” Merck CEO and President Robert M. Davis said.

The authorisation is based on positive results from an interim analysis of a Phase 3 study, which included 775 participants. The results showed that just 7.3 per cent of patients treated with molnupiravir were hospitalised within 29 days.

On the other hand, among patients who received a placebo, 14.1 per cent were hospitalised or died by day 29.

No deaths were reported in patients who were given molnupiravir within the 29-day period, while eight deaths were reported in placebo-treated patients.

The drug’s efficacy was not affected by timing of symptom onset or underlying risk factor. In addition, based on the participants with available viral sequencing data (approximately 40 per cent of participants), molnupiravir demonstrated consistent efficacy across viral variants Gamma, Delta, and Mu.

Molnupiravir has also been shown to be active in several preclinical models of SARS-CoV-2, including for prophylaxis, treatment, and prevention of transmission.

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-Top News USA

US FDA panel backs booster shot for elderly, high risk groups

Members of the committee expressed doubts about the safety of a booster dose in younger adults and teens…Reports Asian Lite News

A Food and Drug Administration (FDA) advisory panel has endorsed a booster shot of the Pfizer-BioNTech Covid-19 vaccine six months after full inoculation in people above 65 years and for individuals at high risk for severe disease.

The decision late Friday came after members of the FDA’s Vaccines and Related Biological Products Advisory Committee voted against advising the agency to approve boosters for anyone 16 and older after hours of debate, reports Xinhua news agency.

Members of the committee expressed doubts about the safety of a booster dose in younger adults and teens, and said they wanted to see more data about the safety and long term efficacy of a booster dose.

A decision about boosters from the FDA is expected in the next few days.

Meanwhile, another advisory panel of the Centers for Disease Control and Prevention (CDC) is also scheduled to meet next week on how to apply the FDA’s eventual decision and can fine-tune the recommendation.

President Joe Biden’s administration have recently announced a plan to begin administering booster doses to the general population during the week of September 20, pending sign-offs from the FDA and CDC.

The CDC published data on Friday showing that all three Covid-19 vaccines available in the US — Pfizer-BioNTech, Moderna and Johnson & Johnson — still provide strong protection against hospitalisation.

Moderna’s vaccine provided 93 per cent protection against hospitalisation, Pfizer’s was 88 per cent and Johnson & Johnson’s Janssen vaccine was 71 per cent, said the CDC study.

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COVID-19 India News USA

‘FDA decision on Covaxin has no bearing on us’


However, he added, “It’s their decision, it should be respected. Our regulator has endorsed this vaccine and there is no impact on use of Covaxin in our national programme…reports Asian Lite News.

Denial of emergency use authorisation to Bharat Biotech made Covaxin by the United States Food and Drug Administration’s (USFDA) has no bearing on the policies in India said NITI Aayog member (Health) Dr. V.K. Paul.

Stating that every country has its own parameter for approval of vaccinations for its population despite the world sharing a common scientific framework for approval, Paul clarified that India also follows its own regulatory process for approval that is tailor-made for its population. The NITI Aayog member said in a press conference on Friday.

“When our vaccine makers make vaccines for our children, the nutritional status, the genetic background–are taken into account to find out whether the vaccine will be fully effective. If one vaccine is effective on our children, it may not work in Argentina. That is a different cohort of people,” he said.

However, he added, “It’s their decision, it should be respected. Our regulator has endorsed this vaccine and there is no impact on use of Covaxin in our national programme.” He said Covaxin phase-3 clinical trial data would be published in the next 7-8 days.

“We expect that the Covaxin manufacturers will be able to comply with the regulators’ requirement. Our regulator has approved this vaccine. We have enough data on safety and efficacy,” the NITI Aayog member

On issue of Amphotericin-B medicine, he said doctors should not prescribe Liposomal Amphotericin-B. Standard Amphotericin-B could be used in otherwise healthy people without a pre-disposed kidney condition to treat mucormycosis.

“This would ensure that we have a robust availability of this drug,” he pointed out.

FDA (IANS)

Earlier this week, the USFDA announced that it will not provide emergency use authorisation (EUA) to Bharat Biotech’s COVAXIN COVID-19 vaccine.

On the other hand, the US’ top medical regulatory body ‘recommended’ Ocugen Inc, the American partner of the Hyderabad-based vaccine maker, to seek authorisation through the Biologics License Application (BLA).

In March 2021, the USFDA had said that it would not issue further EUAs for Covid-19 vaccines as the US had enough vaccines approved and available for its population. (INN)

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