FDA Approves Pfizer’s Coronavirus Vaccine

The Food and Drug Administration (FDA) on Friday night approved the first coronavirus vaccine for emergency use in the United States, several media outlets reported, clearing the way for U.S. officials to begin vaccinating millions of Americans as early as next week.

The New York Times wrote:

The Food and Drug Administration authorized Pfizer’s Covid-19 vaccine for emergency use on Friday, according to three people with knowledge of the decision who spoke on condition of anonymity because they were not authorized to discuss it. The action means millions of highly vulnerable people will begin receiving the vaccine within days.

The Washington Post also confirmed the news that the FDA has approved the vaccine. The Post wrote:

The Food and Drug Administration on Friday gave emergency use authorization to the nation’s first coronavirus vaccine, launching what scientists hope will be a critical counteroffensive against a pathogen that has killed more than 290,000 Americans, shredded the nation’s social and political fabric and devastated the economy.

The vaccine, from Pfizer and its German partner BioNTech, will reportedly be shipped out in the. millions across America over the next week. The United States joins other countries, including the United Kingdom and Canada, in approving the vaccine. The Pfizer vaccine is administered in two separate doses ,weeks apart, and American officials have been preparing, as the vaccine requires being frozen for a massive undertaking of shipping and storing the vaccine nationwide. Pfizer has said the vaccine has a 95 percent effectiveness rate, without any serious side effects.

This week, U.S. officials from President Donald Trump’s administration gathered with governors at the White House to tout the coming vaccine and lay out a vision for distributing it nationwide.

Trump released a video on Twitter announcing the news of the FDA’s approval of the vaccine, saying it met the “gold standard of safety” of the world’s premiere agency that gauges effectiveness and safety of medicines.

“I have really good news,” Trump said. “Today our nation has achieved a medical miracle. 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 end the pandemic once and for all.”

Trump also touted Operation Warp Speed as helping deliver this vaccine, as his administration through this program put huge funding behind the effort to develop the cure—and to get it distributed out to the general public. The president said that while governors will decide how the vaccine is administered in their states, “the first vaccine will be administered in less than 24 hours.”

He also said that all Americans will be able to get it for free.

“We have made sure that this vaccine will be free for all Americans,” Trump said.

Senior officials from the Trump administration celebrated the news too.

“It is nothing short of a medical miracle to have FDA authorization of a vaccine for COVID-19 just over 11 months since the virus was made known to the world,” Health and Human Services Secretary Alex Azar said in a statement. “Because of President Trump’s strong leadership and unwavering support for Operation Warp Speed, we have millions of doses of this vaccine that are now being shipped to every corner of America, with administration to begin as soon as providers are ready. The triumph of Operation Warp Speed is a tribute to dedicated public servants across HHS and the Department of Defense, our partners in the private sector, and incredible American scientists. This vaccine, like any vaccine FDA potentially authorizes, has been through multiple stages of safety review, and it has shown extraordinary effectiveness in protecting people from the virus. Vaccines will help bring this pandemic to an end, which is all the more reason to double down on the public health measures we need to stay safe in the coming months. As Americans get vaccinated, we need to continue taking steps like washing our hands, social distancing, and wearing face coverings to protect ourselves, our loved ones, and our communities.”

Acting Defense Secretary Christopher Miller, whose Department is overseeing the logistics side of vaccine distribution through Operation Warp Speed, praised servicemen and women who are leading the effort to get the vaccine out all across America.

“The massive logistical planning our military has contributed to Operation Warp Speed gives me even more pride in the talent and dedication of our service members,” Miller said. “They have been crucial in bringing a safe and effective vaccine to the American people and in restoring the health of our country.”

Vaccines normally take years to develop and receive approval, but Trump’s Operation Warp Speed–part of the White House Coronavirus Task Force effort under the president’s leadership–sped up the process significantl, having one ready in less than a year since the novel coronavirus pandemic first broke out across the United States and around the world.

In an exclusive interview with Breitbart News in April, FDA commissioner Dr. Stephen Hahn estimated that the vaccine may take as long as a year to 18 months from then to develop and approve–so this nine-month timetable is truly record-setting.

“On vaccine development, as you know it takes time for vaccines,” Hahn said in early April. “In record time, a company in collaboration with the FDA and U.S. government—and N.I.H. was involved with this too—a company has gotten a vaccine into clinical trials. That’s a safety clinical trial, so the earliest—we’re working with a number of manufacturers, so PHARMA and vaccine manufacturers have stood up and really leaned in on this one. We are working with a number of manufacturers, and there are a number of promising candidates. We’re working hard to accelerate that timetable. Typically it takes years. Dr. Fauci has mentioned on TV that it may take 12 to 18 months. I think that is a typical and reasonable timeframe. But I don’t want the American people to think we’re resting on a standard timetable here. We’re really pushing hard to try to accelerate things here. There’s a number of things we can do from a regulatory point of view and with respect to manufacturing capacity to help the clinical trials get performed so they’re as efficient as possible—and also around sharing of data. This is where industry where again, normally as competitors, they have committed to sharing so we can have the absolute best products in the hands of the American people and that includes vaccines.”

But this process was not without its hiccups. Other countries had approved the vaccine first, before the FDA here in the United States, and the FDA’s advisory committee had recommended its approval earlier this week. Several media outlets reported that White House Chief of Staff Mark Meadows leaned in on Hahn Friday to ensure the FDA got final emergency approval across the finish line this week– or else he’d be fired– reportedly that some at FDA pushed back on. Hahn himself said that the media reports of such a phone call were inaccurate.

The virus, which intelligence officials agree emanated from Wuhan, China, has completely upended the world and the United States for the past nine months. The FDA approval of the Pfizer vaccine, and looming potential approvals of other vaccine candidates, gives hope to an otherwise grim pandemic that has shaken the world. It also completely changed the trajectory of the 2020 presidential campaign, as Democrat candidate former Vice President Joe Biden made Trump’s response to the pandemic a centerpiece of his campaign. While Trump continues to challenge the election results, Biden is currently the certified winner in well more than enough states to easily secure an electoral college victory. Next week, those electors will, barring any last-second surprises, formally be slated for Biden–all while the coronavirus vaccine is administered to the first of what is expected to be millions of Americans who eventually get it–capping a tumultuous year in American politics, health, and science.