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Pfizer Reports No Major Issues After Expanding Trial to 44,000 People; Vaccine Looks “Safe”

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Pharmaceutical giant Pfizer has said that its candidate vaccine for COVID-19 looks potentially safe. The company believes it will have the necessary data on the vaccine’s efficacy by next month. In the event of an emergency authorization, the company will also disclose the safety data to the public. Pfizer CEO Albert Bourla added, “Transparency is a must, particularly given this situation and the politicization of the vaccine,” he told journalists during a call with the press.

The company was looking to expand its trial area from 30,000 to 44,000 now to include teenagers between 16 to 18 years of age, as well as patients with HIV and Hepatitis. This move, according to Bourla, was because of the safety data for the vaccine was extremely positive. 

So far, according to the data released, the participants who took part in the drug trial – both young and old – have only complained of headaches and other minor side effects. The trial involves an active vaccine and a placebo. While some of the participants were given the active vaccine, others were given the placebo. 

Pfizer’s senior VP and Head of Vaccine Research and Development, Kathrin Jansen, shared that there were a few health issues during the trial that were considered serious. According to the safety panel, none of the problems were related to the vaccine. Jansen believes that the expanded pool of patients could help conduct a closer study of the vaccine, specifically its effect on patients with pre-existing health conditions, and even patients infected with the virus before they received the vaccine.

The BNT162 is manufactured in three plants across the USA, and in Germany and Belgium. Currently, three scenarios about the vaccine’s effectiveness are being considered. According to Dr. Mikael Dolsten, Pfizer’s Chief Scientific Office, either people will need an annual shot or a one-shot vaccine, like polio. “It’s reasonable also to assume that we need maybe in the future a boost because this is a real pandemic and there’s going to be a lot of virus circulating even after global [vaccination] campaigns,” said Dolsten. 

Transport becomes a significant issue for vaccine developers because the BNT162 can only be kept frozen on dry ice for a limited number of days (15) and refrigerated for an additional five days before being used on patients. Although Pfizer doesn’t believe that this will be a factor initially since the demand for the vaccine will be very high. “No dose is going to be lying around for very long,” said Angela Hwang, President of the Pfizer Biopharmaceuticals Group. Bourla ended the call with journalists by lamenting the politicization of the vaccine. But he is also happy that this pandemic will boost the pharmaceutical industry’s image.

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