USA issues emergency approval to Pfizer-BioNTech Covid vaccine

USA issues emergency approval to Pfizer-BioNTech Covid vaccine

Also Read | India's COVID-19 Tally Rises to 98,57,029, Death Toll Mounts to 1,43,019: Live Breaking News Headlines & Updates, December 13, 2020. Moderna, which is due to be considered by the FDA in the coming week.

FDA said the shot can be used for people age 16 and over.

The prescribing instructions don't preclude use of the vaccine in pregnant women or women who are breastfeeding, but they say that there isn't enough information to assess the effects of the vaccine or its risks under those circumstances. It also said that vaccination sites should have "appropriate medical equipment" to manage immediate allergic reactions.

The FDA said their analysis confirmed that the vaccine was safe and provided 95 per cent protection.

But, after two health care workers in Britain who received the injection suffered severe allergic reactions, the FDA has advised people who have known allergies to the vaccine's ingredients to avoid getting it.

A full list of ingredients in the Pfizer-BioNTech vaccine is available online.

The Food and Drug Administration released its letter to Pfizer granting the authorization Friday evening.

The decision to approve capped a day of drama after it was widely reported in the USA media that the White House had threatened to fire the FDA chief Stephen Hahn if he did not issue the approval on Friday. That prompted the agency to accelerate its announcement, originally planned for Saturday.

While messenger RNA vaccines have several advantages, they are also more risk in terms of side-effects and are potentially less effective in the long-term. "There is no political influence", he said. "We've been planning for months with daily calls, drilling down to really quite minute details", said Wes Wheeler, president of the company's health care division, in an interview on Saturday. "And the final 66 sites on Wednesday, which will complete the initial delivery of the Pfizer-BioNTech vaccine", he said.

While DPH does not plan to mandate the vaccine, it is strongly encouraging that people get vaccinated once doses become available.

Offit is the director of the Vaccine Education Center at Children's Hospital of Philadelphia and one of the 17 members of the advisory board to vote to recommend the vaccine Thursday.

Mr Trump said the vaccine had already been distributed across the country and state leaders would decide who would get the vaccinations.

Different groups - such as teachers and essential workers - are jostling for a place near the front of the line behind health care workers and the elderly. Healthcare workers and elderly people in long-term care facilities in the USA are expected to be the main recipients of a first round of 2.9 million doses. By Sunday morning, those vaccines will move from manufacturing facilities to distribution hubs across the country.

South African Health Products Regulatory Authority (Sahpra) said the government hopes to receive its first vaccines from the global Covax global vaccine scheme in the second quarter of 2021.

Dr. Mohga Kamal Yanni of the People's Vaccine Alliance warned that "the current system, where pharmaceutical corporations use government funding for research, retain exclusive rights, and keep their technology secret to boost profits, could cost many lives".

Both companies said the shipments would be closely tracked and monitored, and would be given priority over other packages.

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