US gives final nod to emergency use of Pfizer-BioNTech COVID-19 vaccine
First dose in 'less than 24 hours'
Washington, Dec 12: The US has given a final nod for the emergency use of Pfizer's COVID-19 vaccine, paving the way for its use in the country worst-hit by the pandemic, with the first dose set to be administered in less than 24 hours.
The US Food and Drug Administration (FDA) on Friday issued the emergency use authorisation (EAU) to the vaccine developed by American pharmaceutical giant Pfizer and its German partner BioNTech to combat the disease that has killed over 294,000 people in the country.
Today our nation has achieved a medical miracle. We have delivered a safe and effective medicine in just nine months, US President Donald Trump said in a video soon after the FDA approval.
"We have delivered a safe and effective vaccine in just nine months. This is one of the greatest scientific accomplishments in history. It will save millions of lives and soon end the pandemic once and for all. I am thrilled to report that the FDA has authorised the Pfizer vaccine, Trump said.
The US is the first nation in the world to produce a verifiably safe and effective vaccine. Today's achievement is a reminder of America's unlimited potential, Trump said, adding that it would be provided free to Americans.
I'm proud to say that we have made sure that this vaccine will be free for all Americans. Through our partnership with FedEx and UPS, we have already begun chipping the vaccine to every state and zip code in the country. The first vaccine will be administered in less than 24 hours, Trump said.
FDA Commissioner Stephen M. Hahn described it as a significant milestone in battling this devastating pandemic that has affected so many families in the US and around the world.
In a statement issued late Friday night, FDA said that it has determined that the vaccine has met the statutory criteria for issuance of an EUA. The totality of the available data provides clear evidence that the vaccine may be effective in preventing COVID-19.
The data also support that the known and potential benefits outweigh the known and potential risks, supporting the vaccine's use in millions of people 16 years of age and older, including healthy individuals.
In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information, it said.
Today's action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency's career scientists to ensure this vaccine met FDA's rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorisation, Dr Hahn said.
The tireless work to develop a new vaccine to prevent this novel, serious, and life-threatening disease in an expedited time frame after its emergence is a true testament to scientific innovation and public-private collaboration worldwide, he said.
FDA said the vaccine contains messenger RNA (mRNA), which is genetic material. The vaccine contains a small piece of the SARS-CoV-2 virus's mRNA that instructs cells in the body to make the virus's distinctive spike protein.
When a person receives this vaccine, their body produces copies of the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2, it said.
While not an FDA approval, today's emergency use authorisation of the vaccine holds the promise to alter the course of this pandemic in the US, said Peter Marks, director of the FDA's Center for Biologics Evaluation and Research.
With science guiding our decision-making, the available safety and effectiveness data support the authorisation of the vaccine because the vaccine's known and potential benefits clearly outweigh its known and potential risks, he said.
The Pfizer vaccine has already been approved for the public in the UK, Canada, Mexico, Bahrain and Saudi Arabia.
In his video, Trump said that his administration gave Pfizer and other companies a great deal of money, hoping this would be the outcome, and it was. He thanked all of the brilliant scientists, technicians, doctors and workers who made this all possible.
Pfizer and Moderna have announced their vaccine is approximately 95 per cent effective, far exceeding expectations. These vaccines are also very safe, he asserted.
This will quickly and dramatically reduce deaths and hospitalisations. When the China virus invaded our shores, I promised that we would produce a vaccine in record time before the end of the year. They said it couldn't be done. But with today's announcement, we have now achieved that goal, he said.
"The pandemic may have begun in China, but we are ending it right here in America, Trump said.
US Chamber of Commerce President Suzanne P. Clark said that with this, the US has turned a corner in the fight against the pandemic.
From the beginning, the business community has harnessed its innovation and ingenuity to deliver solutions to eradicate the virus and end the global pandemic. The development and delivery of a safe and effective vaccine at unprecedented speed is an historic example of the power of private industry to change the world for the better, Suzanne said.
According to the Johns Hopkins data, the US has 15,834,965 COVID-19 cases.
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India, Ethiopia elevate ties to strategic partnership as PM Modi holds talks with his counterpart
Addis Ababa (PTI): India and Ethiopia on Tuesday elevated their historical ties to a strategic partnership, as Prime Minister Narendra Modi held wide-ranging talks with his Ethiopian counterpart Abiy Ahmed Ali during which they discussed issues of bilateral and mutual interest.
Modi, who arrived here from Jordan on his maiden bilateral visit, was accorded a ceremonial welcome at the National Palace ahead of the bilateral talks, reflecting the vibrant India-Ethiopia relations rooted in shared history and a promising future.
"We are elevating India and Ethiopia relations to a strategic partnership. This step will provide new energy, new momentum and new depth to our ties," Prime Minister Modi said during the delegation-level talks.
He thanked PM Ali for his support in India's fight against terrorism. "The support of friendly countries in this struggle against terrorism holds great significance," Modi said.
"Today, we got the opportunity to deliberate on the key aspects of our cooperation, such as economy, innovation, technology, defence, health, capacity-building and multilateral cooperation. I am pleased that today, we have decided to double the student scholarship for Ethiopia in India," Modi said.
Modi said that India and Ethiopia have shared contact, dialogue, and exchange for thousands of years. The two countries, which are rich in languages and traditions, are symbols of unity in diversity, he added.
"Both countries are democratic powers committed to peace and the welfare of humanity. We are co-travellers and partners of the Global South. On international platforms, we have stood shoulder-to-shoulder," he said.
The two sides signed eight MoUs/agreements, including upgrading ties to 'Strategic Partnership', customs cooperation, establishing data center at the Ethiopian Foreign Ministry, UN Peacekeeping training cooperation, debt restructuring under G20, more ICCR scholarships and AI short courses for Ethiopians, and support for maternal and neonatal healthcare.
Modi said the African Union's headquarters in Ethiopia makes the country a meeting point of African diplomacy. "Inspired by the common vision of an inclusive world, in 2023, India ensured that the African Union became a G20 member," he said.
In 2023, during India’s G20 Presidency, the African Union was admitted as a permanent member of the G20.
Modi said that though this is his first visit, he felt a deep sense of belonging and warmth, reflecting the thousands of years of connection between the two countries.
On his part, Prime Minister Ali said the two countries share over thousands of years of connection through trade, diplomacy, education, culture and even in our food and traditions. "These ties continue to shape a deep friendship, collaboration and mutual respect between our people," he said.
"We also appreciate your consistent message that Africa's priorities must lead the partnership. These kinds of dignified, respectful messages for Africa are very important. Mr Prime Minister, keep pushing. That is the type of message we are expecting from all our trusted friends," Ali said.
He said this aligned fully with Ethiopia's development plan - African-owned, African-led, and African-defined.
"Today, we meet with a clear focus to shape a modern partnership, grounded in sovereignty, self-reliance and practical cooperation. Our cooperation is rooted in equality and South-South solidarity," he said.
"Our economy is performing strongly. Last year, we grew 9.2% and this year we are expecting 10.3% GDP growth. Besides GDP growth, our FDI inflow is also rising big time. India is the leading source for our FDI," he said.
"We have more than 615 Indian companies which are investing in Ethiopia. This all gives our cooperation a strong foundation of trust. I think our decision today that we elevate our historic relationship to a strategic relationship is the right decision," he added.
Ethiopia also conferred its highest award - The Great Honour Nishan of Ethiopia - on PM Modi. He is the first global head of state to receive this award.
Prime Minister Modi also went to the Friendship Park and Friendship Square in Addis Ababa with PM Ali.
In a warm and special gesture, PM Modi was earlier received by his Ethiopian counterpart at the airport and accorded a warm and colourful welcome.
"Ethiopia is a nation with great history and vibrant culture," Modi said.
PM Ali informed his Indian counterpart about the varieties of Ethiopian coffee during informal talks.
"At Addis Ababa airport, took part in a traditional Coffee Ceremony with Prime Minister Abiy Ahmed Ali. The ceremony beautifully highlights Ethiopia’s rich heritage," Modi said.
In a unique gesture, the Ethiopian Prime Minister drove Modi to the hotel.
On the way, he took a special initiative of taking PM Modi to the Science Museum and Friendship Park, which was not in the itinerary.
"Gratitude to Prime Minister Abiy Ahmed Ali for showing me glimpses of Ethiopian history and culture at the National Palace Museum in Addis Ababa. It was a powerful reminder of Ethiopia’s rich traditions," Modi said in a post on X.
The Nobel Peace Prize-winning Ethiopian PM’s special gestures show remarkable respect for Modi, sources said.
"Thank you Ethiopia for a welcome that was unforgettable. The Indian community showed remarkable warmth and affection. India-Ethiopia friendship is going to get even more robust in the times to come," Modi said.
When Modi arrived at the hotel, he was warmly welcomed by the members of the Indian community. Local artists performed dances. Some of them danced on the theme of the popular Hindi song 'Aisa Des Hai Mera' to welcome him.
On Wednesday, Modi will address the Joint Session of Parliament and share his thoughts on India's journey as the "Mother of Democracy" and the value that the India-Ethiopia partnership can bring to the Global South.
PM Modi arrived in Ethiopia from Jordan, where he held a one-on-one meeting with King Abdullah II at the Husseiniya Palace on Monday before the delegation-level talks.
India and Jordan also inked MoUs in the fields of culture, renewable energy, water management, digital public infrastructure and twinning arrangement between Petra and Ellora, aimed at giving a major boost to bilateral ties and friendship.
From Ethiopia, Modi will visit Oman on the final leg of this three-nation tour.
