WH nixes FDA guidelines on vaccine approval

WASHINGTON — The White House has blocked new Food and Drug Administration guidelines on bringing potential vaccines for COVID-19 to market that likely would have prevented their approval before the Nov. 3 election.

At issue was the FDA’s planned requirement that participants in mass clinical trials for vaccines be followed for two months to ensure there are no side effects and the vaccines provide lasting protection. Despite the move by the White House, FDA officials say companies are aware of the standards and are expected to comply with them.

FDA Commissioner Stephen Hahn has been attempting to shore up public confidence in the FDA’s vaccine review for weeks, vowing that career scientists, not politicians, will decide if the shots are safe and effective for mass vaccination.

President Donald Trump has repeatedly insisted that a vaccine could be authorized before Election Day, despite top government scientists saying that timeline is very unlikely.


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HERE’S WHAT YOU NEED TO KNOW ABOUT THE VIRUS OUTBREAK:

— India has 61,267 new cases, its lowest daily increase since Aug. 25.

— In Africa, 15 vaccine clinical trials underway

— Italy weighing mandatory mask wearing outdoors

— Trump’s return to the White House puts focus on staff possibly exposed if no protocols.

— Some survivors and kin of those who have died are angry over Trump’s advice not to fear COVID-19.

— White House blocks FDA guidelines on bringing potential vaccines to market that would almost certainly prevent approval before election.

— Follow AP’s pandemic coverage at http://apnews.com/VirusOutbreak and https://apnews.com/UnderstandingtheOutbreak

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HERE’S WHAT ELSE IS HAPPENING:

KUALA LUMPUR, Malaysia — Prime Minister Muhyiddin Yassin, along with seven ministers and six deputy ministers, are observing a voluntary two-week quarantine.

They attended a meeting on Oct. 3 with a minister who tested positive for the coronavirus after returning from Sabah. Malaysia’s police chief and the health director-general attended the meeting and are isolating at home.

Coronavirus cases in Malaysia spiked to a new daily record of 691 on Tuesday. There’s been four new deaths, including a one-year-old baby. Muhyiddin ruled out another national lockdown, saying measures will be targeted to curb transmission in hotspot zones.

The cases Tuesday pushed the totals to 13,504 infections and 141 deaths.

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JOHANNESBURG — Fifteen clinical trials of COVID-19 vaccines are underway across the African continent, according to a comment published in the journal Nature by Africa Centers for Disease Control and Prevention.

Five trials are occurring in South Africa and four in Egypt, with a single trial each in Guinea-Bissau, Ghana, Uganda, Kenya, Zambia and Zimbabwe.

African nations have teamed up to combat the pandemic, with painful memories of millions of Africans dying in the decade it took for affordable HIV drugs to become available on the continent.

“Africa has ended up at the end of the queue every time” in the race for disease therapies, the Nature comment said. But COVID-19 has jolted the African Union into jointly pursuing vaccine trials and vaccine manufacturing.

The Africa CDC estimates the continent will need 1.5 billion vaccine doses, enough to give 60% of the population the two doses likely required. Vaccines and delivery could cost up to $10 billion, and delivery across the vast continent will be a major challenge.

The Nature comment indicates that authorities are willing to partner with beverage companies, noting that “refrigerated bottles of Coca-Cola are available in even the remotest areas of Africa.”

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ROME — Italy’s health minister says the government is examining a proposal to make masks mandatory outdoors, with the number of infections growing steadily for the last nine weeks.

Roberto Speranza says as infections spread, it is necessary to return to restrictions that were gradually loosened over the spring and summer months after Italy’s strict nearly three-month lockdown.

The government is expected to pass new measures by Wednesday making it necessary to wear masks outdoors and limit gatherings. The government also wants to extend the state of emergency put into place on Jan. 31, while the epidemic was still believed confined to China, until the end of January 2022, making it easier to enforce new measures on a national level.

Speranza said the recent uptick in cases has been primarily from gatherings of friends and acquaintances, making it even more pressing for people to wear masks in the presence of those not living in the same household. He noted there are currently 58,900 cases of the virus in Italy, compared with 12,600 two months ago, an indication of how it is spreading even if it is well below the peaks of last March and April.

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LONDON — The European Medicines Agency has begun reviewing a second potential coronavirus vaccine in an expedited process that could grant approval earlier than normal if it proves safe and effective.

In a statement Tuesday, the EU regulator said it has started examining early laboratory data from a COVID-19 vaccine being developed by BioNTech and Pfizer.

“This does not mean that a conclusion can be reached yet on the vaccine’s safety and effectiveness, as much of the evidence is still to be submitted to the committee,” the EMA said. It added that the agency’s decision to start the expedited approval process was based on preliminary results from studies in adults which suggest the vaccine triggers the body’s immune system to fight COVID-19.

Advanced tests involving thousands of people getting the vaccine developed by BioNTech and Pfizer are ongoing and results will likely become available in the coming months.

Last week, EMA announced it had begun a similar fast-track approval process for a coronavirus vaccine still being tested by Oxford University and AstraZeneca. The expedited process means an approval could be granted in weeks rather than months.

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TOKYO — Japan and South Korea have agreed to resume business travel between them starting Oct. 8, according to the Japanese Foreign Ministry. South Koreans will be able to enter Japan for business and conduct work but will be required to undergo a 14-day quarantine after entry, the ministry said in a statement Tuesday.

South Korea has reported slightly more than 400 deaths from the coronavirus, while Japan has confirmed about 1,600.

Japan has imposed an entry ban on people from many countries because of the pandemic. The ban has been gradually relaxed, including for travelers from Thailand, Singapore and Vietnam, although a 14-day quarantine is required.

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NEW DELHI — India has registered 61,267 new coronavirus cases, its lowest daily increase since Aug. 25.

The country with nearly 6.7 million reported infections has had the highest single-day increases in the world for nearly 45 days. The last three weeks, however, have seen a gradual decline.

The Health Ministry on Tuesday also reported 884 deaths in the past 24 hours. The death toll now stands at 103,569.

India has the second-highest number of reported infections and is on track to exceed the caseload in the United States within weeks.

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COLOMBO, Sri Lanka — Sri Lanka has confirmed that more than 300 garment factory workers have been infected with the coronavirus, after reporting its first community infection in two months.

The health ministry says 321 cases have been identified in the cluster as of Tuesday after the first patient was diagnosed at a hospital two days ago.

To contain the outbreak, the government imposed a curfew in two suburbs of the capital where the majority of patients live, closed schools and universities, and imposed restrictions on public transport.

For more than two months, Sri Lanka health officials have said they have prevented a community spread of the virus and all diagnosed patients had belonged to two known clusters.

The country has reported 3,471 cases and 13 deaths.

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