U.S. surpasses 17 million coronavirus cases

Vaccine development is a complex process that typically takes years, . yet Moderna was the second vaccine maker last month to seek authorization for a COVID-19 vaccine. About a week earlier, Pfizer and its German partner BioNTech had asked for emergency use authorization for their vaccine, which had had a 95% efficacy rate. One reason for the speed of vaccine development was that both vaccines adapted messenger RNA technology developed years ago for other medical research. Unlike other vaccines, the mRNA vaccines don’t use a live virus. Instead, these give cells instructions to make a harmless protein piece to trigger an immune system response. Dr. Colleen Kelley and others also attribute the speed to an unprecedented amount of money from the federal government, more than $9 billion

The U.S. has officially recorded more than 17 million cases of the coronavirus, according to the latest figures from Johns Hopkins University’s School of Medicine.

The nation continues to lead the world in the number of cases, ahead of India’s 9.9 million, and deaths, with more than 307,700. Brazil is second with more than 183,000 deaths.

The number of Americans applying for unemployment benefits rose again last week to 885,000, the highest weekly total since September, as a resurgence of coronavirus cases threatens the economy’s recovery from its springtime collapse.

The Labor Department said Thursday the number of applications increased from 862,000 the previous week. It showed that nine months after the virus paralyzed the economy, many employers are still slashing jobs as the pandemic forces more business restrictions and leads many consumers to stay home. The number of claims was much higher than the 800,000 that economists had expected.

Congressional negotiators on the long-delayed $900 billion COVID-19 economic relief package worked through a handful of remaining holdups Thursday as they labored to seal a final agreement for more help to businesses and the unemployed and new stimulus payments to most Americans.

The central elements of the hard-fought compromise appeared in place: more than $300 billion in aid to businesses; a $300-per-week bonus federal jobless benefit and renewal of soon-to-expire state benefits; $600 direct payments to individuals; vaccine distribution funds; and money for renters, schools, the Postal Service and people needing food aid.

Also Thursday, a second COVID-19 vaccine moved closer to joining the nation’s fight against the pandemic as government advisers convened for a public review of its safety and effectiveness.

It’s the next-to-last step for the vaccine developed by drugmaker Moderna and the National Institutes of Health. The panel of physicians and medical researchers is expected to endorse it, followed by the Food and Drug Administration’s OK within hours or days.

The action would provide a boost to the largest vaccination effort in U.S. history that kicked off this week. More shipments of the first greenlighted vaccine, developed by Pfizer and BioNTech, were going out Thursday, earmarked for health care workers and nursing home residents around the country.

A second vaccine is urgently needed as coronavirus infections, hospitalizations and deaths continue to rise in the U.S. ahead of holiday travel and gatherings that are expected to further fuel the pandemic.

The FDA’s Dr. Doran Fink opened Thursday’s meeting reiterating that the agency’s review would be “transparent, scientifically sound and data-driven.”

Moderna’s vaccine is largely following the same path as Pfizer-BioNTech’s, which relies on the same groundbreaking technology. Most traditional vaccines use dead or weakened virus, but both of the new vaccines use snippets of COVID-19′s genetic code to train the immune system to detect and fight the virus. Both require two doses, weeks apart.

The rapid development of two highly effective vaccines using the novel technique is one of the scientific triumphs in the race against the coronavirus.

“This is coming much faster than what anybody thought,” said Dr. Jesse Goodman of Georgetown University, the former chief of the FDA’s vaccine division. “Something that might have otherwise taken several years — to take this new vaccine technology and test it and approve it — was compressed into within a year.”

But he added both vaccines have only been studied in volunteers for a few months and more follow-up is needed to answer important questions, such as how long protection lasts.

A speedy FDA ruling seems almost certain after the agency issued a positive review Tuesday confirming the Moderna shot’s safety and effectiveness. Either way, Moderna’s vaccine will remain experimental as the company’s two-year study of 30,000 people continues.

If authorized by the FDA, U.S. officials said the initial shipment of nearly 6 million doses would go to health workers and nursing homes. The new vaccine needs to be stored at regular freezer temperatures but not the ultra-cold required for Pfizer-BioNTech’s shot.

On its first day of vaccinations with the Pfizer-BioNTech shot, Britain reported two serious allergic reactions among people who had a history of allergies so severe that they always carried EpiPens. And on Wednesday, officials in Alaska reported an allergic reaction in a health worker who had no known allergies to vaccines.

The FDA said the Pfizer-BioNTech vaccine can be given to anyone who doesn’t have a history of allergic reactions to one of its ingredients, such as polyethylene glycol, a chemical found in many drugs and foods.

The FDA found no severe allergic reactions in Moderna’s data but flagged a slightly higher rate of less serious hypersensitivity reactions among participants who got the vaccine, compared with those receiving a dummy shot.

Regulators also noted three cases of Bell’s palsy, which temporarily paralyzes facial muscles, among vaccine recipients, compared with just one among those getting a dummy shot. The FDA review said the role of the shot in potentially triggering the cases in the vaccine group “cannot be ruled out.”

Similar cases were reported during the review of Pfizer’s vaccine. Ultimately, the FDA said it would carefully monitor the problem as the vaccine rolls out.

Vice President Mike Pence will receive the coronavirus vaccine on Friday in a television broadcast, while President-elect Joe Biden will reportedly be vaccinated sometime next week.

On Tuesday, Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, urged Biden and Vice President-elect Kamala Harris to get vaccinated for COVID-19 as soon as possible.