Pfizer submits COVID-19 vaccine to FDA, China leads distribution

The Sinovac Biotech Coronavirus Test Vaccine Box is on display at the Palacio Bandeirantes on November 19, 2020 in Sao Paulo, Brazil. Rodrigo Paiba / Getty Images

With COVID-19 cases reaching new highs in just a few weeks remaining in the turbulent 2020, pharmaceutical companies around the world are struggling to overcome the last mile of approving and widely distributing effective vaccines. I will.

On Friday, US vaccine frontrunner Pfizer submitted a long-awaited application to the Food and Drug Administration seeking an emergency license for the experimental COVID-19 vaccine BNT162. Earlier this week, pharmaceutical giants declared scientific success for the vaccine, saying late-stage study data showed that it was 95% effective in preventing coronavirus and was completely safe.

“The application in the United States represents an important milestone in our journey to bring the COVID-19 vaccine to the world, giving us a more complete picture of both the vaccine’s efficacy and safety profile. We are confident in that possibility, “says Pfizer. Chairman and CEO Albert Bourla said in a statement released Friday morning.

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Pfizer’s vaccine uses synthetic messenger RNA (mRNA) to COVID-19, similar to the vaccine developed by front runner Moderna, who has published excellent efficacy data but is waiting for safety clearance. It is based on a new technology that activates the immune system against. Two shots are required every three weeks.

The FDA will soon approve Pfizer’s application. A group of agency vaccine advisors will meet early next month to discuss Pfizer and other COVID vaccines. Meanwhile, the CDC is working on a distribution plan for who will be vaccinated first.

Overseas, Chinese vaccine manufacturers are rapidly experimenting with several COVID-19 vaccines in a large population. In a press release this week, the company said a vaccine developed by state-owned pharmaceutical giant Shinofarm was given to nearly one million people as part of an emergency use program, but no serious side effects were reported.

Sinofarm Chairman Liu Jing Jen said vaccinated people include construction workers, diplomats and students who traveled to more than 150 countries during the pandemic. Since late April, China has been able to keep most of the coronavirus away from the soil, so it was necessary to send vaccine test participants abroad to see if the vaccine actually worked.

“For example, one of the overseas offices of a multinational company has 99 employees, 81 of whom are vaccinated,” Liu explained. “Then, an outbreak occurred in the office, 10 out of 18 unvaccinated people were infected, and none of the vaccinated people were infected.”

China’s state-owned pharmaceutical company has several vaccine candidates in large-scale international trials. Beijing has approved the emergency use of several experimental vaccines since June. One of them manufactured by Sinovac recently signed a contract with Brazil to export 46 million batches to South American countries. The Brazilian government is also discussing import plans with other vaccine developers, including Pfizer, Johnson & Johnson, Bharat Biotech of India, and the manufacturer of Sputnik V vaccine in Russia.

All Chinese vaccines are widespread in the United States, even if the United States faces a shortage of locally developed vaccines (which is very likely) because the FDA does not recognize China’s certification process. I will not.

“There are many vaccines in China that look promising at the technical level, but they are unlikely to be widely used outside of China because they have not been submitted to the” gold standard “regulators,” Bill Gates said. Was asked at a meeting last month about the global distribution of the COVID-19 vaccine.

Pfizer's COVID-19 vaccine arrives at FDA, China reports huge test results

Pfizer submits COVID-19 vaccine to FDA, China leads distribution

Source link Pfizer submits COVID-19 vaccine to FDA, China leads distribution

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