Pfizer’s COVID-19 Vaccine Arrives at FDA, China Reports Huge Trial Results

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Pfizer’s COVID-19 Vaccine Arrives at FDA, China Reports Huge Trial Results Photo

A box of Sinovac Biotech coronavirus trial vaccine is displayed at Palacio Bandeirantes on November 19, 2020 in Sao Paulo, Brazil. Rodrigo Paiva/Getty Images

With only a few weeks left in a tumultuous 2020 and COVID-19 cases reaching new highs, drugmakers around the world are scrambling to get through the last mile of getting a working vaccine approved and distributed far and wide.

On Friday, U.S. vaccine frontrunner Pfizer submitted the long-awaited application to the Food and Drug Administration for an emergency use authorization for its experimental COVID-19 vaccine, BNT162. Earlier this week, the pharma giant declared the scientific success of the vaccine, saying that late-stage trial data have shown that it’s 95 percent effective in preventing the coronavirus and is perfectly safe.

“Filing in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential,” Pfizer chairman and CEO Albert Bourla said in a statement released Friday morning.

Like the vaccine developed by frontrunner Moderna, which has also announced great efficacy data but still waiting on safety clearance, Pfizer’s vaccine is based on a novel technology using synthetic messenger RNA (mRNA) to activate the immune system against COVID-19. It requires two shots, given three weeks apart.

The FDA is expected to sign off Pfizer’s application very soon. A group of the agency’s vaccine advisors is set to meet early next month to discuss Pfizer’s and other COVID vaccines. Meanwhile, the CDC is working on a distribution plan about who will get vaccinated first.

Overseas, Chinese vaccine makers are making rapid progress in experimenting with several COVID-19 vaccines on a large population. One vaccine, developed by state-owned pharma giant Sinopharm, has been given to nearly one million people as part of an emergency-use program with no serious side effects reported, the company said in a press release this week.

Chinese state-owned drugmakers have several vaccine candidates in large-scale, international trials. Beijing has authorized emergency use of a few of experimental vaccines since June. One of them, made by Sinovac, has recently struck a deal with Brazil to export 46 million doses to the South American country. The Brazilian government is also in talks with other vaccine developers, including Pfizer, Johnson & Johnson, India’s Bharat Biotech and the maker of Russia’s Sputnik V vaccine, on import plans.

None of the Chinese vaccines will make its way to America, though, even if the U.S. faces a shortage of locally developed vaccines (which is very likely), as the FDA doesn’t recognize China’s certification process.

“China has a number of vaccines that, at a technical level, look promising. But because they haven’t been submitted to a ‘gold standard’ regulator, they’re unlikely to be used extensively outside of China,” Bill Gates said during a conference last month when asked about global distribution of COVID-19 vaccines.

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