Brazil suspends COVID vaccine trials after ‘adverse incident’ – Dateway

Just hours after announcing a breakthrough in the effort to develop a safe and effective COVID-19 vaccine, Brazil halted late-stage clinical trials of another potential vaccine.

The country’s health regulator Anvisa announced Monday it was suspending testing of CoronaVac, developed by Chinese pharmaceutical company Sinovac, after a “serious adverse event” with a volunteer participant. The event happened on October 29, but the statement did not go into details.

Clinical trials in Brazil are being carried out by the Butantan research institute, based in Sao Paulo. Dimas Covas, the head of the state-run institute, told a local television station that a volunteer had died, but the death was not due to the vaccine.

The Sinovac vaccine is the third to be suspended after a volunteer fell ill after being inoculated. US pharmaceutical giant Johnson & Johnson suspended advanced clinical trials of its COVID-19 vaccine last month, while another US-based drugmaker AstraZeneca suspended advanced testing of a vaccine developed with the University of Oxford in September after a volunteer in Britain was diagnosed with transverse myelitis, an inflammatory syndrome that affects the spinal cord and is often triggered by infections.

It’s not uncommon for clinical trials to be put on hold if a volunteer becomes ill so that organizers can determine if the illness is due to the vaccine. But Brazilian President Jair Bolsonaro, who has often expressed his distrust of China, openly doubted the effectiveness of the Sinovac vaccine and insisted his government would not buy the drug.

New drug COVID

Better news came earlier today from the U.S. Food and Drug Administration, which approved the emergency use of the first antibody drug for people with mild to moderate cases of COVID-19.

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The drug, known as bamlanivimab, was developed jointly by US drug maker Eli Lilly and Canadian biotech company AbCellera. It’s part of a class of treatments known as monoclonal antibodies, which are designed to act like immune cells that scientists hope they can fight off the virus. The antibody treatment was similar to that given to U.S. President Donald Trump after he tested positive for COVID-19 early last month.

The FDA has approved the drug for people aged 12 and older who are at risk of developing a severe form of COVID-19.

A clinical trial of the drug conducted by the National Institute of Allergy and Infectious Diseases was canceled late last month after researchers found it was not effective in treating patients hospitalized with advanced disease. disease.

News of the approval of Eli Lilly’s antibody drug, coupled with Pfizer’s announcement that its investigational vaccine was 90% effective in preventing the virus in participants without evidence of prior infection, came the same day. that the United States has passed 10 million COVID-19 in total. cases, including more than 100,000 new cases on Monday, with the New York Times reporting more than 130,000 cases.

The United States has added an average of more than 100,000 new cases a day over the past week, double its daily infections compared to a month ago. About 900 people die every day.

The Midwestern states are hardest hit, with hospitalization rates in the region reaching record highs. The COVID-19 follow-up project said more than 59,000 people were hospitalized across the country on Monday.

COVID elsewhere

COVID-19 infections have increased in other parts of the world, including Europe, where some governments have instituted lockdown measures to slow the spread of the virus. Globally, the number of confirmed cases exceeds 50 million, with 1.2 million deaths and 33 million people recovered.

The situation is worsening in Italy, where five other regions have been placed in the government’s so-called “orange” of its new three-tier system which imposes varying degrees of restrictions.

The system divides the 20 regions of Italy into three colored areas – red, orange and yellow – with red indicating the most restricted areas and yellow the least restricted.

Abruzzo, Umbria, Tuscany, Liguria and Basilicata will join the southern regions of Puglia and Sicily in the orange or middle ; under this area, residents can move freely in their towns, but cannot leave them, while bars and restaurants are limited to delivery and take-out service.

The northern province of Bolzano has been placed in the red , joining its sister regions of Lombardy, Piedmont, Valle d’Aosta and the southern region of Calabria. Residents of these areas will not be allowed to leave their homes, except for professional or medical reasons.

All of Italy is subject to a 10 p.m. – 5 a.m. curfew, while museums and shopping malls are closed on weekends and high school classes move from face-to-face to the internet.

Italy has 960,373 new confirmed cases of the coronavirus, including 41,750 deaths, according to the Johns Hopkins Coronavirus Resource Center.

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