9 erring body care centers shut in Riyadh    20,000 military emblems confiscated in Riyadh    Al-Samaani visits headquarters of Hague Conference on Private International Law    KSrelief provided over $7bln to support children around the world    Al-Jasser: Saudi Arabia to expand rail network to over 8,000 km    OMODA&JAECOO: Unstoppable global cumulative sales over 360,000 units    Saudi Arabia sees 73.7% rise in investment licenses in Q3 2024    Al Hilal doesn't need extra support to bring new players, CEO says    Rust premieres at low-key film festival three years after shooting    Fate of Gaetz ethics report uncertain after congressional panel deadlocked    Ukraine fires UK-supplied Storm Shadow missiles at Russia for first time    Netanyahu offers $5 million and safe passage out of Gaza to anyone returning a hostage    Indian billionaire Gautam Adani indicted in New York on fraud charges    Rafael Nadal: Farewell to the 'King of Clay'    Indonesia shocks Saudi Arabia with 2-0 victory in AFC Asian Qualifiers    Sitting too much linked to heart disease –– even if you work out    Yemeni Orchestra's captivating performances in Riyadh, showcasing shared cultural legacies    Future of Ronaldo's Al Nassr contract remains undecided, says Saudi Pro League CEO    GASTAT report: 45.1% of Saudis are overweight    Denmark's Victoria Kjær Theilvig wins Miss Universe 2024    Order vs. Morality: Lessons from New York's 1977 Blackout    India puts blockbuster Pakistani film on hold    The Vikings and the Islamic world    Filipino pilgrim's incredible evolution from an enemy of Islam to its staunch advocate    Exotic Taif Roses Simulation Performed at Taif Rose Festival    Asian shares mixed Tuesday    Weather Forecast for Tuesday    Saudi Tourism Authority Participates in Arabian Travel Market Exhibition in Dubai    Minister of Industry Announces 50 Investment Opportunities Worth over SAR 96 Billion in Machinery, Equipment Sector    HRH Crown Prince Offers Condolences to Crown Prince of Kuwait on Death of Sheikh Fawaz Salman Abdullah Al-Ali Al-Malek Al-Sabah    HRH Crown Prince Congratulates Santiago Peña on Winning Presidential Election in Paraguay    SDAIA Launches 1st Phase of 'Elevate Program' to Train 1,000 Women on Data, AI    41 Saudi Citizens and 171 Others from Brotherly and Friendly Countries Arrive in Saudi Arabia from Sudan    Saudi Arabia Hosts 1st Meeting of Arab Authorities Controlling Medicines    General Directorate of Narcotics Control Foils Attempt to Smuggle over 5 Million Amphetamine Pills    NAVI Javelins Crowned as Champions of Women's Counter-Strike: Global Offensive (CS:GO) Competitions    Saudi Karate Team Wins Four Medals in World Youth League Championship    Third Edition of FIFA Forward Program Kicks off in Riyadh    Evacuated from Sudan, 187 Nationals from Several Countries Arrive in Jeddah    SPA Documents Thajjud Prayer at Prophet's Mosque in Madinah    SFDA Recommends to Test Blood Sugar at Home Two or Three Hours after Meals    SFDA Offers Various Recommendations for Safe Food Frying    SFDA Provides Five Tips for Using Home Blood Pressure Monitor    SFDA: Instant Soup Contains Large Amounts of Salt    Mawani: New shipping service to connect Jubail Commercial Port to 11 global ports    Custodian of the Two Holy Mosques Delivers Speech to Pilgrims, Citizens, Residents and Muslims around the World    Sheikh Al-Issa in Arafah's Sermon: Allaah Blessed You by Making It Easy for You to Carry out This Obligation. Thus, Ensure Following the Guidance of Your Prophet    Custodian of the Two Holy Mosques addresses citizens and all Muslims on the occasion of the Holy month of Ramadan    







Thank you for reporting!
This image will be automatically disabled when it gets reported by several people.



FDA authorizes third coronavirus vaccine in US
Published in The Saudi Gazette on 28 - 02 - 2021

The US Food and Drug Administration (FDA) authorized Johnson & Johnson's COVID-19 vaccine Saturday. It is the first single dose COVID-19 vaccine available in the US, and is one that "checks nearly all the boxes."
The FDA announced in a statement that it has issued "an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
"The EUA allows the Janssen COVID-19 Vaccine to be distributed in the US for use in individuals 18 years of age and older," it added.
In this regard, Acting FDA Commissioner Janet Woodcock said "The FDA, through our open and transparent scientific review process, has now authorized three COVID-19 vaccines with the urgency called for during this pandemic, using the agency's rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization."
For his part, President Joe Biden said, "This is exciting news for all Americans, and an encouraging development in our efforts to bring an end to the crisis. We know that the more people get vaccinated, the faster we will overcome the virus, get back to our friends and loved ones, and get our economy back on track."
"I want to be clear: This fight is far from over," he warned. "As I have said many times, things are still likely to get worse again as new variants spread, and the current improvement could reverse. There is light at the end of the tunnel, but we cannot let our guard down now or assume that victory is inevitable. We must continue to remain vigilant, act fast and aggressively," he stressed.
The FDA had already approved vaccines developed by Pfizer-BioNTech and Moderna.
With more than 28.5 million confirmed COVID-19 cases and over 511,000 reported deaths in the US since the start of the pandemic, and while the demand for vaccine still far exceeds supply, these vaccines can't come soon enough.
"A third safe and effective vaccine is very welcome news," Andy Slavitt, the White House's senior for COVID Response, tweeted on Friday.
"We need a vaccine that can be quickly mass produced," Dr. Greg Poland, head of the Mayo Clinic's Vaccine Research Group, said Friday. "We'd want to see a reasonable duration of efficacy and protection.
The vaccine was tested in more than 44,000 people in the US, South Africa and Latin America. Globally, it was 66.1% effective against moderate to severe/critical COVID-19 at least four weeks after vaccination, according to an FDA analysis. In the US, it is considered 72% effective, and offered 86% protection against severe forms of the disease.
"One dose will keep you out of the hospital, keep you out of the intensive care unit, and keep you out of the morgue," Dr. Paul Offit, a vaccine adviser to the FDA, told CNN's Wolf Blitzer on Friday. The vaccine comes with few side effects, most of which are mild, including pain at the injection site, headache, fatigue and muscle pain.
Overall, non-fatal serious adverse events were infrequent, according to the FDA's analysis, and there were no reported cases of anaphylaxis following vaccination in the trial. There have been a small number of severe allergic reactions with the Moderna and Pfizer/BioNTech vaccines.
More research is needed, but the FDA analysis also hinted that the J&J vaccine may help prevent asymptomatic infections. A January study from the CDC showed that most coronavirus cases are spread by people without symptoms. If a vaccine prevented asymptomatic infection, it might help reduce opportunities to transmit the disease — not just keep the vaccinated from getting sick.
With so much positive data, an independent group of advisers voted unanimously on Friday to recommend the emergency use authorization of the J&J vaccine. — Agencies


Clic here to read the story from its source.