Leading pharma companies are going to release a common statement expressing their intention of not to seek regulatory approval until they have established that their vaccine candidates are 100 per cent effective and safe for public use.
Even as governments in different countries are willing to ease the regulatory guidelines for approval of a COVID-19 vaccine in order to speed up a public launch, the leading vaccine producing companies have decided not to seek approvals for their vaccines until the efficacy of their vaccines has been completely established. Quoting a report from the Wall Street Journal, The Indian Express reported that leading pharma companies are going to release a common statement expressing their intention of not to seek regulatory approval until they have established that their vaccine candidates are 100 per cent effective and safe for public use. The joint statement draft is being prepared and expected to be released by early next week. The pharma companies which are expected to undersign the joint statement include Pfizer, US biotech company Moderna, and Johnson & Johnson, among others.
The move by the pharma companies could dash the hopes of the likes of US President Donald Trump who is trying to get the first shot of the vaccine administered to the public as early as before the Presidential elections in the country on November 3. It is widely believed that the early release of the vaccine could help the President in his re-election bid. The Food and Drug Administration (FDA), the drug regulator in the United States, has also acknowledged its willingness to launch the vaccine early if the benefits of doing so outweigh the risks of the move. It has also said that even before the scheduled completion of the third phase human trials of the vaccine, the approval could be granted to a vaccine. In tune with the signals provided by the US administration and regulator FDA, the Centres of Disease Control and Prevention (CDC) has also begun preparations for the roll-out of the vaccine in the month of November itself.
However, drugmaker Pfizer, which is reported to be at the forefront of releasing the joint statement, has itself been excited to release the vaccine at an early date. Only two days ago, the company had said that by the end of October it would have enough data to prove whether its vaccine candidate is effective or not. It had also added that soon after it receives enough data, the company would apply for the regulatory approval for the vaccine.
In a separate development, Pakistan has started the third phase clinical trials of the vaccine produced by the Chinese state-owned Sinopharm. In addition to Pakistan, the Chinese firm has signed deals with countries like the UAE, Peru, Morocco, Bahrain, Jordon, among others. China has already approved three vaccine candidates produced in the country, including the Sinopharm vaccine for public use. However, phase 3 trials of these 3 candidates have not been completed.