A health worker administers a dose of the Johnson & Johnson vaccine (Janssen) against COVID-19, on Aug 5, 2021 at the Ambreck pharmacy, in Milan. (MIGUEL MEDINA / AFP)
MILAN / CHICAGO / MOSCOW – Italian doctors and nurses suspended from work because they are not vaccinated against COVID-19 will soon be reinstated, new Health Minister Orazio Schillaci said on Friday.
The move is motivated by a worrying shortage of medical personnel together with declining cases of COVID-19. The new government will also cancel fines imposed on all people aged over 50 who had not got vaccinated, he added.
"A measure is being finalized that will allow the reintegration into service of health staff subject to suspension proceedings for non-compliance with compulsory vaccination before the expiry date of the suspension," he said in a statement posted on the ministry's website.
Italy has been one of the country's hardest hit by the pandemic, with almost 179,000 deaths, according to World Health Organization figures.
Former prime minister Mario Draghi's government had made vaccination mandatory for teachers and health workers in 2021 and extended that to everyone over 50 in January this year.
A refusal resulted in suspension from work without pay for public employees, while those aged over 50 faced fines of 100 euros ($99.5).
The statement added that the minister considers a gradual return to normality to be appropriate and would suspend the daily publication of data on the spread of the epidemic, hospitalisations and deaths. The information will now be released on a weekly basis.
This file photo dated April 20, 2021 shows an exterior view of the European Medicines Agency (EMA) in Amsterdam, the Netherlands. (PETER DEJONG / FILE / AP)
European Medicines Agency
A European Medicines Agency committee on Friday recommended adding heavy menstrual bleeding to the list of side effect of mRNA COVID-19 vaccines made by Moderna, as well as Pfizer and its partner BioNTech.
Reports of heavy periods – bleeding characterised by increased volume and/or duration that interferes with the quality of life – have been observed during clinical trials, from cases in the real world and in medical literature, the EMA said.
The cases – which have mostly been non-serious and temporary in nature – have been reported after the first, second and booster doses of Pfizer-BioNTech's Comirnaty and Moderna's Spikevax, it added.
The regulator has now concluded that there is at least a "reasonable possibility" that heavy menstrual bleeding is causally associated with these vaccines.
A Moderna spokesperson said the company was aware of reports linking its vaccine to dysmenorrhea, or pain associated with menstruation.
"However, at this point, we have not identified a causal association with Moderna’s COVID-19 vaccine, Spikevax."
Pfizer and BioNTech were not immediately available for comment.
The EMA also said that there was no evidence to suggest that the menstrual disorders experienced by some have any impact on reproduction and fertility.
Overall, the totality of data continues to show that the benefits of these vaccines greatly outweigh the risks, the agency reiterated on Friday.
Russia
Russia registered 6,803 new COVID-19 cases in the past 24 hours, taking the nationwide tally to 21,423,725, the official monitoring and response center said Sunday.
The center said the nationwide death toll increased by 75 to 390,104, while the number of recoveries grew by 9,008 to 20,796,124.
Meanwhile, Moscow reported 730 new cases, taking its total to 3,230,288.
An elderly couple wearing protective face masks against COVID-19 walks past the Pfizer Inc headquarters on Dec 9, 2020 in New York City. (ANGELA WEISS / AFP)
United States
The US National Institutes of Health's $1 billion RECOVER Initiative has picked Pfizer Inc's antiviral drug Paxlovid as the first treatment it will study in patients with long COVID-19, organizers of the study said on Thursday.
The complex medical condition involves more than 200 symptoms ranging from exhaustion and cognitive impairment to pain, fever and heart palpitations that can last for months and even years following a COVID-19 infection.
According to details of the study, posted on Clinicaltrials.gov, the randomized, placebo-controlled trial will test Pfizer's treatment or a placebo in 1,700 volunteers aged 18 and older.
The Duke Clinical Research Institute is supervising the study, which is scheduled to start on Jan. 1.
The trial will investigate a leading theory of the cause of long COVID-19, which holds that fragments of the virus persist in the tissues of some individuals, causing prolonged symptoms.
Patients in several case studies have reported improvements in their symptoms after taking Pfizer's antiviral treatment, and several physicians have called for the drug to be studied in a large, scientifically rigorous study in patients with long COVID-19.
Paxlovid, which combines a new Pfizer pill with the old antiviral ritonavir, is currently authorized for use in the first days of a COVID-19 infection to prevent severe disease in high-risk patients.
Estimates of long COVID-19 prevalence range from 5 to 50 percent of people who have had a COVID-19 infection. It affects people who have had both mild and severe COVID-19, including children, and can be severe enough to keep people out of work.