Pharmaceutical company Pfizer on Thursday said data showed that a third shot of its Covid-19 vaccine “may be beneficial within six to 12 months” after the second dose to attain the highest levels of protection against the virus.
However, hours after the company’s announcement, the United States Food and Drug Administration and the Centers for Disease and Control released a joint statement saying that completely vaccinated Americans do not need a booster shoot for now.
Companies Pfizer and BioNTech in a statement sais, “As seen in real world data released from the Israel Ministry of Health, vaccine efficacy in preventing both infection and symptomatic disease has declined six months post-vaccination, although efficacy in preventing serious illnesses remains high.” It added that though “protection against severe disease remained high across the full six months, a decline in efficacy against symptomatic disease over time and the continued emergence of variants are expected.”
The companies also noted that the Delta variant, first detected in India, has become a dominant variant in several countries. In June, a study conducted by the Oxford University found that Pfizer’s vaccine was effective against the Delta and Kappa variants.
“While protection against severe disease remained high across the full six months, a decline in efficacy against symptomatic disease over time and the continued emergence of variants are expected,” the drug maker said in the statement on Thursday.
Pfizer said it was planning to seek emergency use authorisation from the United States Food and Drug Administration for its booster shot in August. But this will be done after the company releases more data on the efficacy of a third shot of the vaccine, according to CNN.
However, the American authorities said that they were looking into “science-based, rigorous process to consider whether or when a booster might be necessary”, reported Bloomberg News. “This process takes into account laboratory data, clinical trial data, and cohort data – which can include data from specific pharmaceutical companies, but does not rely on those data exclusively.”
Pfizer’s Chief Executive Officer Albert Bourla had said in June that the company’s Covid-19 vaccine was in the final stages to get an approval for use in India. The company is already in talks with the Centre to roll out five crore doses between July and October this year.
On June 1, the Indian government had waived the requirement to conduct post-launch bridging trials for foreign-made coronavirus vaccines in a move that is expected to bolster the availability of the shots. The Drugs Controller General of India has also done away with the mandatory testing of every batch of such vaccines at the Central Drugs Laboratory in Kasauli.
Pfizer has obtained indemnity in several countries where its vaccine is already in use, including the United States. Indemnity provides protection to vaccine makers against legal proceedings and costs of compensation for severe side effects among those who receive the shots.