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What you need to know about coronavirus on Thursday, December 3

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US Food and Drug Administrator (FDA) Dr. Stephen Hahn was summoned to the White House twice in two days to explain why the authoritative body had not yet approved the vaccine, which was submitted to the FDA on November 20. The vaccine was formally submitted to the UK’s equivalent body — the Medicines and Healthcare Products Regulatory Agency (MHRA) — on November 23. The UK will begin vaccinating tens of thousands of people by early next week.
So how did the UK get there first? It’s partly to do with the MHRA’s use of rolling data, Zamira Rahim writes.

The MHRA began reviewing data from Pfizer and BioNTech in October, looking at each “package” of data as soon as it became available, rather than considering an entire dataset at the end. Regulators essentially had already seen the vast majority of the data before the final authorization application was even submitted.

Moncef Slaoui, chief adviser to the Operation Warp Speed in the US, said the UK’s approval of the vaccine should give Americans more confidence in it, describing the MHRA as “an external regulatory agency of the highest caliber and standards equivalent to those of the FDA.”

But Dr. Anthony Fauci, the country’s leading infectious disease expert, claimed the MHRA did not scrutinize the trial data as carefully as the FDA, which is doing its review “the correct way,” in his opinion. He added he expected the US to “be there very soon” in its own approval of the vaccine.

The MHRA typically relies on drug companies’ presentation of data, where the FDA has the resources to conduct its own reanalysis of companies’ raw data, Professor Stephen Evans from the London School of Hygiene & Tropical Medicine explains. CNN has reached out to the MHRA for more details of how it conducted its review.

In a pres conference on Wednesday, however, MHRA chief Dr. June Raine insisted that “no corners have been cut” and, in a written statement, assured its review involved experts “poring over hundreds of pages and tables of data, methodically reviewing the data.”

YOU ASKED. WE ANSWERED

Q: What will a Covid-19 vaccine feel like?

A: The Pfizer/BioNTech and Moderna vaccines both use mRNA, which means that rather than giving our bodies a germ or virus, they teach our bodies to produce a protein which then triggers our immune system to make antibodies. So if we get infected with the real virus, our body is prepared to fight it.

Different people will react differently to vaccines, but data shows that there are few side effects. Yasir Batalvi, 24, who took part in a Moderna trial said the first jab felt “just like a flu shot, which is basically just a little pinch in the side of your arm.” mRNA vaccines need two doses, and that’s where Batalvi felt some minor side effects, like a low-grade fever, and fatigue and chills. But he said it only put him out for a day and he “felt ready to go by the next morning.”

Feeling under the weather does not mean that you have contracted Covid-19 from the vaccine. In fact, experts say having this kind of reaction shows that your body is responding the way it should. Read more here.
Send your questions here. Are you a health care worker fighting Covid-19? Message us on WhatsApp about the challenges you’re facing: +1 347-322-0415.

WHAT’S IMPORTANT TODAY

Barack Obama, George W. Bush and Bill Clinton to get jabs

The three former presidents are volunteering to be vaccinated for Covid-19 on camera to promote public confidence in the jab’s safety once the FDA authorizes one, Jamie Gangel and Shelby Lin Erdman write.
It’s a campaign likely to infuriate President Trump, who is claiming the lion’s share of credit for the unprecedented speed of development of several vaccines but has otherwise shown little leadership during the pandemic, Stephen Collinson writes.

US hits record daily deaths as authorities warn of ‘rough’ three months

Johns Hopkins University reported 3,157 US deaths on Wednesday, the highest daily number since the country’s first few cases were reported 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 were also confirmed, as US Centers for Disease Control and Prevention Director Dr. Robert Redfield warned the winter was going to be “the most difficult in the public health history of this nation, largely because of the stress that’s going to put on our health care system.”

Germany extends its partial lockdown

German Chancellor Angela Merkel announced late Wednesday that all states across the country would extend their Covid-19 restrictions until January 10, as the country joined the US in reporting a record number of daily deaths. A total of 487 people died and more than 20,000 infections were recorded, according to the Robert Koch Institute, Germany’s public health agency.

Restrictions — including the closure of restaurants, bars and leisure facilities — had been due to end on December 20, ahead of the Christmas period. Germany’s coronavirus response was seen as a model for the world in the pandemic’s early months, but the country is now battling a spike in infections and its world-renowned hospital system is under strain.

ON OUR RADAR

Angelina Friedman got a big party for her 101st birthday and was crowned prom queen at her nursing home last year.

TOP TIPS

As Christmas approaches, some people are wondering if it’s OK to mark the occasion by attending church services. The US Supreme Court last week voted 5-4 to reject restrictions on religious services that New York Gov. Andrew M. Cuomo had put in place. The same court made the opposite decision on religious restrictions in California and Nevada earlier. So what to do?

No matter where you are in the world, the 1918 flu pandemic — when some churches closed their doors and others remained opened — offers some valuable lessons here, Kristen Rogers writes.

TODAY’S PODCAST

“Internet access isn’t that common as people think it is. There are plenty of parts of the country that don’t even have it. And that includes in big urban areas like where I am in New York City.” — CNN Correspondent Evan McMorris-Santoro

CNN Chief Medical Correspondent Dr. Sanjay Gupta and McMorris-Santoro talk about how parents, students and educators are navigating a school year of connectivity issues, teacher burnout and a record increase in failing grades. Listen Now.

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