Coronavirus Vaccines Being Developed By Pfizer, BioNTech Given ‘Fast Track’ Status By FDA

The designation could speed up the regulatory review process, potentially putting a vaccine on the market faster.

a patient receives an injection
whitesession / Pixabay

The designation could speed up the regulatory review process, potentially putting a vaccine on the market faster.

Potential vaccines for the novel coronavirus currently being developed a major drug manufacturer and its corporate partner have been granted “fast track” approval by the Food and Drug Administration (FDA), Reuters reported. The designation could mean that the vaccine gets produced and deployed sooner than would otherwise be required for a new drug.

Pharmaceutical giant Pfizer and its partner, BioNTech, have been working to make a coronavirus vaccine, as have multiple other drug manufacturers in the U.S. and abroad. In the case of Pfizer, two potential candidates seem to show promise: BNT162b1 and BNT162b2. In ongoing clinical trials being carried out in the U.S. and in Germany, test subjects who were given the potential vaccines had more COVID-19 antibodies in their system after 28 days than typically seen in people who were infected with the coronavirus.

The manufacturers hope to expand their clinical trials to include as many as 30,000 participants in the coming month.

The “fast track” approval the FDA has given to those companies means that the ordinary review process for new drugs will be sped up, potentially getting the drug deployed faster.

“The FDA’s decision to grant these two COVID-19 vaccine candidates Fast Track designation signifies an important milestone in the efforts to develop a safe and effective vaccine against SARS-CoV-2,” said Peter Honig, Senior Vice President, Global Regulatory Affairs, Pfizer, said in a statement via MarketWatch.

syringes and medicine
  qimono / Pixabay

Honig also promised to work closely with the FDA under the program deemed “Project Lightspeed” to get a coronavirus vaccine developed quickly. The companies hope to have 100 million doses of the vaccine ready by the end of the year — assuming it’s found safe and effective and given approval — and 1.2 billion doses by the end of 2021.

Meanwhile, multiple other drug manufacturers around the world are also working to get a coronavirus vaccine up and running as soon as possible. Back in May, Moderna Inc, was granted the same “fast track” status to get a vaccine developed. As the Department of Health and Human Services reported, drugmaker AstraZeneca has partnered with the federal government to develop a vaccine and deploy 300 million doses of it by as early as October 2020.

However, research is showing that a vaccine for the coronavirus may prove harder to come by than originally thought. As previously reported by The Inquisitr, a new study from the United Kingdom shows that coronavirus antibodies can disappear in as little as a few weeks, potentially meaning that patients would have to get immunized against it repeatedly in order to maintain immunity.