The US Food and Drug Administrator (FDA) Dr. Stephen Hahn was called to the White House twice within two days to explain why the relevant agency had not yet approved the vaccine, which was filed with the FDA on November 20. The vaccine was formally submitted to the UK equivalent – the Medicines and Health Products Regulatory Authority (MHRA) – on November 23rd. The UK will start vaccinating tens of thousands of people early next week. How did Britain get there first? This has in part to do with the MHRA’s use of rolling data, writes Zamira Rahim.
The MHRA began reviewing Pfizer and BioNTech’s data in October, examining each “packet of data” as it became available rather than looking at an entire data set at the end. Regulators had essentially seen the vast majority of the data before the final permit request was even filed.
Moncef Slaoui, chief advisor to Operation Warp Speed in the US, said the UK’s approval of the vaccine should give Americans more confidence, describing the MHRA as “an outside regulator of the highest caliber and standards on par with the FDA. ” . “
Dr. However, Anthony Fauci, the country’s leading infectious disease expert, claimed the MHRA did not review the study data as carefully as the FDA, which he believes is doing its review “the right way.” He added that he expected the US “would be there very soon” if it approved the vaccine itself.
The MHRA typically relies on the presentation of data by pharmaceutical companies where the FDA has the resources to re-analyze the raw data from the companies themselves, explains Professor Stephen Evans of the London School of Hygiene & Tropical Medicine. CNN reached out to MHRA for more details on how to conduct their review.
In a presidential conference on Wednesday, MHRA boss Dr. June Raine insisted, however, that “no compromises were made,” and affirmed in a written statement that experts “rummage through hundreds of pages and tables of data and methodically check the data”.
YOU ASKED. WE HAVE ANSWERED
Q: What will a Covid-19 vaccine feel like?
ONE: The Pfizer / BioNTech and Moderna vaccines both use mRNA, which means that they don’t give our bodies a germ or virus, but instead teach our bodies to produce a protein which then triggers our immune system to make antibodies. So when we become infected with the real virus, our body is ready to fight it.
Different people react differently to vaccines, but data shows that there are few side effects. Yasir Batalvi, 24, who was in a Moderna trial, said the first bump felt “like a flu shot that’s basically just a tiny pinch in the side of your arm”. mRNA vaccines require two doses, and this is where Batalvi experienced some minor side effects, such as a mild fever and fatigue and chills. But he said it would only turn him off for a day and he “felt ready to go the next morning”.
Feeling under the weather doesn’t mean you got Covid-19 from the vaccine. In fact, experts say this type of response shows that your body is responding the way it should. Read more here. Submit your questions here. Are you fighting Covid-19 in healthcare? Drop us a message on WhatsApp about the challenges you are facing: +1 347-322-0415.
WHAT’S IMPORTANT TODAY?
Barack Obama, George W. Bush, and Bill Clinton all get jabs
The three former presidents volunteer to vaccinate against Covid-19 on camera to boost public confidence in the safety of the sting as soon as the FDA authorizes one, write Jamie Gangel and Shelby Lin Erdman. It’s a campaign likely to enrage President Trump, who is claiming the lion’s share of the credit for the unprecedented pace of multiple vaccine development, but otherwise shown little leadership during the pandemic, writes Stephen Collinson.
US hits record daily deaths as authorities warn of “tough” three months
Johns Hopkins University reported 3,157 deaths in the US on Wednesday, the highest daily number since the country first fell in January. The record is more than 20% higher than the previous one, when 2,603 people died on April 15.
More than 200,000 new Covid-19 infections have also been confirmed when the director of the U.S. Centers for Disease Control and Prevention Dr. Robert Redfield, warned that winter was going to be “the most difficult in the history of public health in this country,” largely because of the stress that will put a strain on our health system. “
Germany extends its partial lockdown
Chancellor Angela Merkel announced late Wednesday that all states across the country would extend their Covid-19 restrictions until January 10 as the country, along with the US, reported a record number of daily deaths. According to the Robert Koch Institute, the German health department, a total of 487 people died and more than 20,000 infections were registered.
The restrictions – including the closings of restaurants, bars and leisure facilities – should end on December 20th before the Christmas season. The German coronavirus response was seen as a role model for the world in the first few months of the pandemic, but the country is now battling a surge in infections and its world-renowned hospital system is under pressure.
ON OUR RADAR
- 102-year-old Angelina Friedman experienced the flu in 1918 and survived cancer. She also hit the coronavirus – twice.
- A group of researchers had been working on a remote atoll since February and had only heard of Covid-19. Then they returned to society to see their full effect.
- A couple from Hawaii were arrested over the weekend after allegedly flying home knowing they had both tested positive for Covid-19.
- Covid-19 is rising in South Korea, but half a million students took a notoriously difficult college entrance exam on a marathon test day anyway.
- According to the CDC, quarantine times for Americans can be reduced to 7 or 10 days. But 14 days is still the safest option. The following has changed.
- The US Department of Defense has released pictures of a Covid-19 vaccination card. The cards are said to be used to keep track of who had Covid-19 shots.
Just before Christmas, some people wonder if it is okay to mark the occasion by attending church services. The US Supreme Court last week voted 5-4 to oppose restrictions on religious services put in place by New York Governor Andrew M. Cuomo. The same court previously made the opposite ruling on religious restrictions in California and Nevada. What to do?
No matter where you are in the world, the 1918 pandemic flu – when some churches closed their doors and others stayed open – offers some valuable lessons here, writes Kristen Rogers.
“Internet access isn’t as widespread as people think. There are many parts of the country that don’t even have it. And that goes for large urban areas like New York City, too.” – CNN correspondent Evan McMorris-Santoro
Dr. CNN’s Chief Medical Correspondent Sanjay Gupta and McMorris-Santoro discuss how parents, students and educators cope with a school year of connectivity issues, teacher burnout and a record increase in failed grades. Listen now