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| 3rd time’s the charm? Pfizer/BioNTech to study if THREE doses of Covid-19 vaccine can boost immunity against variants | 3rd time’s the charm? Pfizer/BioNTech to study if THREE doses of Covid-19 vaccine can boost immunity against variants |
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| Pfizer and BioNTech will launch a new trial of the Covid-19 vaccine they jointly developed to see if a third dose can act as an effective booster against emerging variants of the virus, they said in a statement on Thursday. | Pfizer and BioNTech will launch a new trial of the Covid-19 vaccine they jointly developed to see if a third dose can act as an effective booster against emerging variants of the virus, they said in a statement on Thursday. |
| The study will use participants from a current US trial, who will be given a booster shot of the current vaccine between six to 12 months after receiving their initial two-dose regimen. | The study will use participants from a current US trial, who will be given a booster shot of the current vaccine between six to 12 months after receiving their initial two-dose regimen. |
| According to the statement, 144 Phase 1 participants across two age groups will receive a third dose – people aged 18-55 and 65-85. | According to the statement, 144 Phase 1 participants across two age groups will receive a third dose – people aged 18-55 and 65-85. |
| The companies also said that, as originally planned, all of the trial participants will be monitored for up to two years. | The companies also said that, as originally planned, all of the trial participants will be monitored for up to two years. |
| “We believe that the third dose will raise the antibody response 10- to 20-fold,” Pfizer CEO Albert Bourla said during an NBC interview. | “We believe that the third dose will raise the antibody response 10- to 20-fold,” Pfizer CEO Albert Bourla said during an NBC interview. |
| In his earlier statement, Bourla said Pfizer has not seen any evidence to suggest that its 95-percent-effective vaccine is less effective against new variants. | In his earlier statement, Bourla said Pfizer has not seen any evidence to suggest that its 95-percent-effective vaccine is less effective against new variants. |
| However, he added that the study is critical to understanding the safety of a third dose and immunity against new variants. | However, he added that the study is critical to understanding the safety of a third dose and immunity against new variants. |
| On Thursday, Pfizer also announced that it will conduct clinical trials for a modified version of its mRNA vaccine against the B.1.351 Covid-19 variant first identified in South Africa. | On Thursday, Pfizer also announced that it will conduct clinical trials for a modified version of its mRNA vaccine against the B.1.351 Covid-19 variant first identified in South Africa. |
| Pfizer confirmed it is in talks with US and EU regulators, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) respectively, about the plans. | Pfizer confirmed it is in talks with US and EU regulators, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) respectively, about the plans. |
| The FDA told manufacturers on Monday to prepare for new variants of the virus, including by testing modified vaccines on those who have already been injected and those who haven’t. | The FDA told manufacturers on Monday to prepare for new variants of the virus, including by testing modified vaccines on those who have already been injected and those who haven’t. |
| The FDA also said that discussions were ongoing into whether, in the future, tweaked vaccines “may be authorized without the need for clinical studies.” | The FDA also said that discussions were ongoing into whether, in the future, tweaked vaccines “may be authorized without the need for clinical studies.” |
| Like this story? Share it with a friend! | Like this story? Share it with a friend! |