Traditionally, clinical, non-clinical, and manufacturing data are required to fully license a vaccine-type drug. A consolidated information on safety and effectiveness of at least six months is required.
The Moderna laboratory asked the United States health authorities for full approval of its Covid-19 vaccine and becomes the second company to require it, after Pfizer, which made the request in early May.
So far, all the vaccines that are being supplied have received an emergency use authorization, a form of permission that, in the United States, is issued by the Food and Drug Administration; in the European Union, by the European Medicines Agency; and in each country by the competent authority.
Well, a full authorization takes much longer, approximately a year, and requires more complex analysis, but it allows laboratories to sell their vaccine directly to consumers and for the drug to remain on the market once the pandemic emergency is controlled. .
Traditionally, the full license for a vaccine-type drug requires clinical, non-clinical, and manufacturing data. A consolidated information on safety and effectiveness is needed for at least six months, which means that the drug continues to actively protect people six months after receiving the necessary doses.
Moderna applied for that full license for its vaccine in people over 18 years old, and Pfizer did the same on May 7 for people over 16 years old.
Just as some nations have established health protocols to generate these approvals, there are other countries that lack these resources and what they do is adhere to the authorizations issued by the World Health Organization, which just approved an eighth vaccine for use by emergency.
“I am pleased to announce that the WHO has licensed the CoronaVac vaccine from Sinovac for emergency use, after verifying that it is safe, effective and its quality is assured after two doses of the inactivated vaccine. CoronaVac’s simple storage requirements make it suitable for low-resource settings, it is the eighth vaccine to receive WHO emergency use authorization, ”said Tedros Adhanom Ghebreyesus, director of the agency.
To date, the vaccines approved for emergency use by the WHO are that of Pfizer / BioNTech, that of Astrazeneca manufactured in South Korea, India, and Europe – which despite being the same drug, are considered to be different- , the Janssen from the Johnson & Johnson laboratory, the one from Moderna, the one from the Chinese laboratory Sinopharm and CoronaVac from Sinovac.