Coronavirus: US may approve BioNTech-Pfizer shot for teens

US regulators are expected to expand emergency use authorization for the BioNTech-Pfizer coronavirus vaccine to include adolescents between the ages of 12 and 15 next week, according to multiple reports on Tuesday.

The decision is set to come nearly a month after the pharma giant released preliminary results from a study conducted on 2,260 youngsters in the proposed age bracket. The vaccine study showed no cases of the coronavirus among fully vaccinated volunteers as opposed to 18 among those given dummy shots.

The shot is already authorized for those above the age of 16.

After approval by the US Food and Drug Administration (FDA), a federal vaccine advisory committee will meet to discuss whether the shot should be recommended for the age group.

The country will start administrating the shots after the Centers for Disease Control and Prevention (CDC) adopts the committee's recommendation, possibly in a matter of days. 

US authorities have said they aim to have 70% of the country's population partially vaccinated by July 4, Independence Day, a goal President Joe Biden is expected to announce later today.

Here's an overview of other major coronavirus-related developments around the world.

Europe

UK Prime Minister Boris Johnson's office on Tuesday announced that he and US Secretary of State Antony Blinken, in London for a meeting of G7 foreign ministers, had "agreed that the global roll out of vaccines will be key to defeating the coronavirus pandemic." The Prime Minister's office said the two "underlined the importance of G7 work in this area, including efforts to increase international manufacturing capability."

The European Medicines Agency (EMA) said on Tuesday that it had begun a rolling review of the Chinese-developed COVID-19 vaccine, Sinovac.

The decision was based on preliminary lab results and is the first step toward authorizing the jab for use in the European Union. Sinovac joins the Russian Sputnik V, US Novavax and German CureVax as potential jabs being investigated by the official body.

Novavax plans to start delivering its coronavirus vaccine to the European Union by the end of this year, Reuters reported. A formal contract could be signed as early as this week.

While Novavax had reached a preliminary deal with the bloc late last year, the final agreement was delayed over a shortage of raw materials. 

Finally, the bloc’s purchases will be dependent on whether the European Medicines Agency (EMA) approves the vaccine. No date has been set for a decision on the vaccine, which hasn’t been approved anywhere in the world.

Germany has reported 7,534 new cases of the virus, according to data from the Robert Koch Institute (RKI) for infectious diseases. The new tally stands at 3,433,516. 

With 315 deaths, the reported death toll has risen to 83,591.

The State Premier of Bavaria Markus Söder said on Tuesday that from May 10, outside dining, theaters, cinemas and opera houses in the state may reopen in areas where the seven-day rate of infection is below 100 per 100,000 people. Amenities will only be allowed to stay open until 10 p.m.

From May 21, the beginning of the Pentecost holiday, regions below the infection threshold will once again be able to welcome tourists.

Italy's Prime Minister Mario Draghi on Tuesday, speaking after a meeting of G20 tourism ministers, announced plans to open his country to travelers before the rest of the EU. Draghi, who made the announcement as the country registered an uptick in daily coronavirus infections and deaths, claimed Italy would be ready to introduce a so-called "green pass" by mid-May, saying "the time has come to book your holidays in Italy."

Portugal's government said it aims to protect migrant fruit and vegetable pickers — mainly from Bangladesh, India, Nepal and Eastern Europe — currently suffering high coronavirus infection rates. The government has entirely closed off two parishes in Odemira in southern Portugal. Over the past 14 days the area has registered 1,910 new infections per 100,000 residents, whereas the average in the rest of the country, which is now emerging from lockdown, stands at 64 cases per 100,000 residents. Prime Minister Antonio Costa called the living conditions a public health risk and a "blatant violation of human rights."
 

Vaccine manufacturer Serum Institute of India will invest in facilities in the UK, according to Prime Minister Boris Johnson. The biotech company, which currently produces the low-cost AstraZeneca coronavirus shot, could also manufacture jabs in the UK going forward. 

According to Johnson’s office, the £240 million ($334 million/276 million euro) project would include a sales office, "clinical trials, research and development and possibly manufacturing of vaccines."

Asia

India has recruited trainee doctors and nurses to help the country combat a massive surge in COVID-19 infections. The government also postponed a nationwide medical post-graduate entrance exam to free up more qualified doctors for the fight. 

As India struggles to contain the pandemic, multiple countries have imposed restrictions on travelers from the country. The US will bar most non-US citizens from entering the United States from India as of Tuesday.

Pfizer said it is in fresh talks with the Indian government over an "expedited approval pathway" for its vaccine, as the county faces a shortage of COVID-19 vaccines for its mass vaccination program.

"We are currently discussing with the Indian government an expedited approval pathway to make our Pfizer-BioNTech vaccine available for use in the country," said Pfizer CEO Albert Bourla.

Americas

Florida’s governor has moved to invalidate all coronavirus restrictions across the state, signing legislation that gives him sweeping powers to do so. The law does not come into effect until July but Governor Ron DeSantis said he will issue an executive order to remove local mask mandates faster. 

"I think this creates a structure that's going to be a little bit more respectful, I think, of people's businesses, jobs, schools and personal freedom," the Republican politician said.

The US pharmaceutical giant Pfizer increased its forecast sales of the BioNTech-Pfizer vaccine this year. The drugmaker expects to achieve full-year sales of $26 billion (€21.6 billion) up from the previous forecast of $15 billion.

Venezuela is set to begin trials of the Cuban coronavirus vaccine candidate Abdala, Health Minister Carlos Alvarado has announced. The country plans to produce enough doses locally to vaccinate 4 million people. 

In Cuba, late-stage trials of the vaccine will be completed in July, with results published in August. 

Mexico hopes to vaccinate its entire population by the end of the final quarter of 2022, the country’s deputy health minister, Hugo Lopez-Gatell, has announced.

The projected timeline takes into consideration possible global delays in vaccine production and delivery to Mexico.

ab, see/rt (AFP, AP, Reuters, dpa)