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If they do find a vaccine by the end of the year, as President Trump suggests, isn't it too soon to tell if it will be safe to get? What is the recommendation here for those of us who have heard at least 12 months are needed to ensure safety?
As of today (May 30, 2020), newspapers reports within the last two days report that two separate Covid vaccine candidates may be ready for use generally by year’s end—one of which may be ready as early as October 2020.
For purposes of use within the United States, the vaccine must be finally approved for use by the Food & Drug Administration based on disciplined and mandatory human clinical trials showing that the vaccine is both safe and effective. Whereas the FDA can authorize experimental and emergency use of a yet to be finally approved vaccine only for patients who are critically ill, widespread use of a vaccine can only begin in the United States if proven through highly regimented FDA prescribed clinical trials that the vaccine is both safe and effective.
Overall and worldwide, more than 100 Covid-related vaccines are in development. Pharmaceutical companies and researchers are working around the clock to develop a Covid vaccine in record time. Normally, development of an approved vaccine takes years. Up until recently, the optimistic conventional wisdom and hope has been for a safe and effective Covid vaccine to be approved and ready in 12 to 18 months—a time period for development that has been considered record time. Yet, reports over the last two days give reason to hope that a successful Covid vaccine can be developed and approved for general use within 9 to 10 months—or even a seven to eight month period.
Today’s media report is on the likelihood that one successful Covid vaccine will be developed in China by the end of this year or early next year with a manufacturing capacity of 100 to 120 million doses. President Xi Jinping has offered assurances that this vaccine will be shared globally. However, the expectation is that 3.5 billion doses will be required for vaccinations globally, which highlights the importance that several vaccines must be proven safe and effective in fight Covid worldwide.
Moreover, for effective distribution, an approved vaccine requires massive production capabilities with the availability of attendant production supplies, for example, vials, which as of now are in short supply. Whichever vaccine proves successful in clinical trials, must have an attendant production capabilities, which will itself be a challenge, to deliver enough of the vaccine.
Yesterday, Pfizer also announced that it, in conjunction with the German pharmaceutical company, BioNTech, may have an approved Covid vaccine ready by as early as this October if its clinical trials continue on the success path created so far.
Similarly, the British drug maker, AstraZeneca, in partnership with Oxford Biomedica, also announced last week that it has high hopes of an approved Covid vaccine by year’s end. AstraZeneca also announced last week that it will receive a $1.2 billion contribution from the United States for development and production of its Covid vaccine—all of which is aimed at delivery and use of a successful Covid vaccine sometime this fall.
Again, it cannot be emphasized enough that clinical trials for these and other vaccines—however successful to date-- still need to be fully and finally completed successfully. To date, the cause for optimism is now based only on preliminary successful trials. Production of successful vaccines remains a separate challenge although promising signs are now present indicating that that challenge, too, can be met. When approved for use, especially within the United States, the developers will have shown through human clinical trials that the vaccines are safe and effective. Before clinical trials are finally approved the U.S. FDA can approve the use of vaccines on an emergency basis for patients who are very sick. Finally, since it is now estimated that 3.5 billion Covid vaccinations will be required worldwide, as many as 8 to 10 separate approved vaccines in the end will be needed to meet that worldwide challenge. Again, based on last week’s reports alone, there is cause for optimism for the approval of that number of vaccines.
